Trial Outcomes & Findings for Acthar Gel in Participants With Pulmonary Sarcoidosis (NCT NCT03320070)

NCT ID: NCT03320070

Last Updated: 2023-02-27

Results Overview

Forced vital capacity (FVC) is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. Based on the absolute change of percent predicted, FVC was evaluated to determine if the condition is: * Improved (+1) \[≥ 5% absolute change\] * Unchanged (0) \[\>- 5% to \< 5% absolute change\], or * Worse (-1) \[≤ -5% absolute change\] An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 55 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2023-02-27

Participant Flow

Participants took part in the study at 35 investigative sites in the United States from 21 February 2018 to 15 November 2021.

The study consisted of 2 phases: a double-blind treatment (DBT) phase and an optional open-label extension (OLE) phase. Out of the 49 participants who completed the DBT phase, 47 participants chose to continue the treatment in the optional OLE phase.

Participant milestones

Measure	Acthar Gel in DBT Then Acthar Gel in OLE Participants received Acthar Gel as a 1 milliliter (mL) injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
DBT Phase (Week 1 to Week 24) STARTED	27	28
DBT Phase (Week 1 to Week 24) Modified Intent-to-Treat Population (mITT)	27	28
DBT Phase (Week 1 to Week 24) Safety Population	27	28
DBT Phase (Week 1 to Week 24) COMPLETED	24	25
DBT Phase (Week 1 to Week 24) NOT COMPLETED	3	3
OLE Phase (Week 25 to Week 48) STARTED	22	25
OLE Phase (Week 25 to Week 48) Open-label Safety Population	22	25
OLE Phase (Week 25 to Week 48) COMPLETED	17	23
OLE Phase (Week 25 to Week 48) NOT COMPLETED	5	2

Reasons for withdrawal

Measure	Acthar Gel in DBT Then Acthar Gel in OLE Participants received Acthar Gel as a 1 milliliter (mL) injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
DBT Phase (Week 1 to Week 24) Adverse Event	1	1
DBT Phase (Week 1 to Week 24) Withdrawal by Subject	2	2
OLE Phase (Week 25 to Week 48) Adverse Event	3	0
OLE Phase (Week 25 to Week 48) Lost to Follow-up	0	1
OLE Phase (Week 25 to Week 48) Non-compliance with Study Drug	1	0
OLE Phase (Week 25 to Week 48) Withdrawal by Subject	1	1

Baseline Characteristics

Acthar Gel in Participants With Pulmonary Sarcoidosis

Baseline characteristics by cohort

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=27 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=28 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Total n=55 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 9.07 • n=5 Participants	54.8 years STANDARD_DEVIATION 11.33 • n=7 Participants	54.2 years STANDARD_DEVIATION 10.21 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	28 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The mITT population included all randomized participants who received at least 1 dose of the IMP and who contributed any efficacy data to the study.

Forced vital capacity (FVC) is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. Based on the absolute change of percent predicted, FVC was evaluated to determine if the condition is:

• Improved (+1) [≥ 5% absolute change]
• Unchanged (0) [>- 5% to < 5% absolute change], or
• Worse (-1) [≤ -5% absolute change]

An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=27 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=28 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24 Improved	10 Participants	7 Participants
DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24 Unchanged	12 Participants	12 Participants
DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24 Deteriorate	1 Participants	3 Participants
DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24 Missing Assessment	4 Participants	6 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase

Forced vital capacity (FVC) is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. Based on the absolute change of percent predicted, FVC was evaluated to determine if the condition is:

• Improved (+1) [≥ 5% absolute change]
• Unchanged (0) [>- 5% to < 5% absolute change], or
• Worse (-1) [≤ -5% absolute change]

An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=22 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=25 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48 Improved	2 Participants	6 Participants
OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48 Unchanged	13 Participants	11 Participants
OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48 Deteriorate	1 Participants	3 Participants
OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48 Missing Assessment	6 Participants	5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The mITT population included all randomized participants who received at least 1 dose of the IMP and who contributed any efficacy data to the study.

The diffusing capacity of the lungs for carbon monoxide (DLCO) measures the ability of the lungs to transfer gas from inhaled air to the red blood cells in the blood. Participants are asked to fully inhale a low concentration of carbon monoxide and an inert tracer gas. Based on the absolute change of percent predicted, DLCO was evaluated to determine if the condition is:

• Improved (+1) [≥ 5% absolute change]
• Unchanged (0) [>- 5% to < 5% absolute change],
• Worse (-1) [≤ -5% absolute change]

An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=27 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=28 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
DBT: Number of Participants in Each Category of Assessment Based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter at Week 24 Improved	5 Participants	4 Participants
DBT: Number of Participants in Each Category of Assessment Based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter at Week 24 Unchanged	11 Participants	11 Participants
DBT: Number of Participants in Each Category of Assessment Based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter at Week 24 Deteriorate	7 Participants	7 Participants
DBT: Number of Participants in Each Category of Assessment Based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter at Week 24 Missing Assessment	4 Participants	6 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase

The diffusing capacity of the lungs for carbon monoxide (DLCO) measures the ability of the lungs to transfer gas from inhaled air to the red blood cells in the blood. Participants are asked to fully inhale a low concentration of carbon monoxide and an inert tracer gas. Based on the absolute change of percent predicted, DLCO was evaluated to determine if the condition is:

• Improved (+1) [≥ 5% absolute change]
• Unchanged (0) [>- 5% to < 5% absolute change],
• Worse (-1) [≤ -5% absolute change]

An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=22 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=25 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
OLE: Number of Participants in Each Category of Assessment Based on the DLCO, a Pulmonary Function Test Parameter at Week 48 Improved	9 Participants	6 Participants
OLE: Number of Participants in Each Category of Assessment Based on the DLCO, a Pulmonary Function Test Parameter at Week 48 Unchanged	3 Participants	6 Participants
OLE: Number of Participants in Each Category of Assessment Based on the DLCO, a Pulmonary Function Test Parameter at Week 48 Deteriorate	4 Participants	8 Participants
OLE: Number of Participants in Each Category of Assessment Based on the DLCO, a Pulmonary Function Test Parameter at Week 48 Missing Assessment	6 Participants	5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The mITT population included all randomized participants who received at least 1 dose of the IMP and who contributed any efficacy data to the study.

High-resolution computer tomography (HRCT) is a type of computed tomography (CT) with specific techniques to enhance image resolution. It is used in the diagnosis of various health problems, most commonly for lung disease. These images show cross sections (slices) through the lungs. HRCT imaging was evaluated by the investigator/radiologist and the central reader to determine if the condition is improved (+1), unchanged (0), or worse (-1). An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=27 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=28 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
DBT: Number of Participants in Each Category of Assessment Based on High Resolution Computer Tomography (HRCT) at Week 24 Improved	2 Participants	1 Participants
DBT: Number of Participants in Each Category of Assessment Based on High Resolution Computer Tomography (HRCT) at Week 24 Unchanged	22 Participants	18 Participants
DBT: Number of Participants in Each Category of Assessment Based on High Resolution Computer Tomography (HRCT) at Week 24 Deteriorate	0 Participants	4 Participants
DBT: Number of Participants in Each Category of Assessment Based on High Resolution Computer Tomography (HRCT) at Week 24 Missing Assessment	3 Participants	5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase

High-resolution computer tomography (HRCT) is a type of computed tomography (CT) with specific techniques to enhance image resolution. It is used in the diagnosis of various health problems, most commonly for lung disease. These images show cross sections (slices) through the lungs. HRCT imaging was evaluated by the investigator/radiologist and the central reader to determine if the condition is improved (+1), unchanged (0), or worse (-1). An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=22 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=25 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
OLE: Number of Participants in Each Category of Assessment Based on HRCT at Week 48 Improved	1 Participants	6 Participants
OLE: Number of Participants in Each Category of Assessment Based on HRCT at Week 48 Unchanged	13 Participants	13 Participants
OLE: Number of Participants in Each Category of Assessment Based on HRCT at Week 48 Deteriorate	1 Participants	2 Participants
OLE: Number of Participants in Each Category of Assessment Based on HRCT at Week 48 Missing Assessment	7 Participants	4 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The mITT population included all randomized participants who received at least 1 dose of the IMP and who contributed any efficacy data to the study.

King's sarcoidosis questionnaire (KSQ) (General Health) is a 28-item questionnaire for participants to indicate the status of their sarcoidosis and treatment. Each item was answered on a 7-point scale where 1 means the participant experiences the symptom all the time and 7 means the participant does not experience the symptom at all. Higher scores indicate improvement, and a change of 4 points is considered clinically meaningful. The score on the scale was evaluated to determine if the condition is:

• Improved (+1) based on a change of ≥ 4 points
• Unchanged (0) based on a change of >- 4 to < 4 points
• Worse (-1) based on a change of ≤ -4 points

An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=27 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=28 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
DBT: Number of Participants in Each Category of Assessment Based on the King's Sarcoidosis Questionnaire (KSQ) (General Health), a Quality of Life Parameter at Week 24 Improved	11 Participants	7 Participants
DBT: Number of Participants in Each Category of Assessment Based on the King's Sarcoidosis Questionnaire (KSQ) (General Health), a Quality of Life Parameter at Week 24 Unchanged	3 Participants	8 Participants
DBT: Number of Participants in Each Category of Assessment Based on the King's Sarcoidosis Questionnaire (KSQ) (General Health), a Quality of Life Parameter at Week 24 Deteriorate	10 Participants	9 Participants
DBT: Number of Participants in Each Category of Assessment Based on the King's Sarcoidosis Questionnaire (KSQ) (General Health), a Quality of Life Parameter at Week 24 Missing Assessment	3 Participants	4 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase.

King's sarcoidosis questionnaire (KSQ) (General Health) is a 28-item questionnaire for participants to indicate the status of their sarcoidosis and treatment. Each item was answered on a 7-point scale where 1 means the participant experiences the symptom all the time and 7 means the participant does not experience the symptom at all. Higher scores indicate improvement, and a change of 4 points is considered clinically meaningful. The score on the scale was evaluated to determine if the condition is:

• Improved (+1) based on a change of ≥ 4 points
• Unchanged (0) based on a change of >- 4 to < 4 points
• Worse (-1) based on a change of ≤ -4 points

An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=22 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=25 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
OLE: Number of Participants in Each Category of Assessment Based on the KSQ (General Health), a Quality of Life Parameter at Week 48 Improved	8 Participants	8 Participants
OLE: Number of Participants in Each Category of Assessment Based on the KSQ (General Health), a Quality of Life Parameter at Week 48 Unchanged	2 Participants	5 Participants
OLE: Number of Participants in Each Category of Assessment Based on the KSQ (General Health), a Quality of Life Parameter at Week 48 Deteriorate	6 Participants	9 Participants
OLE: Number of Participants in Each Category of Assessment Based on the KSQ (General Health), a Quality of Life Parameter at Week 48 Missing Assessment	6 Participants	3 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The mITT population included all randomized participants who received at least 1 dose of the IMP and who contributed any efficacy data to the study.

The fatigue assessment score (FAS) is a 10-item checklist for participants to indicate the level of their fatigue. Each item was answered on a 5-point scale where 1 means the participant does not experience the symptom all and 5 means the participant experiences the symptom all the time. Lower scores indicate improvement (less fatigue) and a change of 4 points is considered clinically meaningful. The score on the scale was evaluated to determine if the condition is:

• Improved (+1) based on a change of ≤ -4 points
• Unchanged (0) based on a change of >- 4 to < 4 points
• Worse (-1) based on a change of ≥ 4 points

An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=27 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=28 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
DBT: Number of Participants in Each Category of Assessment Based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter at Week 24 Improved	6 Participants	6 Participants
DBT: Number of Participants in Each Category of Assessment Based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter at Week 24 Unchanged	12 Participants	11 Participants
DBT: Number of Participants in Each Category of Assessment Based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter at Week 24 Deteriorate	6 Participants	7 Participants
DBT: Number of Participants in Each Category of Assessment Based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter at Week 24 Missing Assessment	3 Participants	4 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase.

The fatigue assessment score (FAS) is a 10-item checklist for participants to indicate the level of their fatigue. Each item was answered on a 5-point scale where 1 means the participant does not experience the symptom all and 5 means the participant experiences the symptom all the time. Lower scores indicate improvement (less fatigue) and a change of 4 points is considered clinically meaningful. The score on the scale was evaluated to determine if the condition is:

• Improved (+1) based on a change of ≤ -4 points
• Unchanged (0) based on a change of >- 4 to < 4 points
• Worse (-1) based on a change of ≥ 4 points

An additional category "Missing Assessment" indicates the participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=22 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=25 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
OLE: Number of Participants in Each Category of Assessment Based on FAS, a Quality of Life Parameter at Week 48 Improved	7 Participants	4 Participants
OLE: Number of Participants in Each Category of Assessment Based on FAS, a Quality of Life Parameter at Week 48 Unchanged	5 Participants	13 Participants
OLE: Number of Participants in Each Category of Assessment Based on FAS, a Quality of Life Parameter at Week 48 Deteriorate	4 Participants	5 Participants
OLE: Number of Participants in Each Category of Assessment Based on FAS, a Quality of Life Parameter at Week 48 Missing Assessment	6 Participants	3 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The mITT population included all randomized participants who received at least 1 dose of the IMP and who contributed any efficacy data to the study.

Corticosteroids are first line treatment for sarcoidosis. Concerns of corticosteroid toxicity led to efforts to taper dose sooner. Participants were clinically evaluated at each visit by investigator and categorized by their condition; dose was tapered using algorithm to take them off prednisone using incremental doses of 40,30,20,10,7.5,5,2.5,0 mg, as explained with each category below.

• Improved: When condition improved, reduce dose by 1 level
• Unchanged:

1. When stable condition without toxicity: At first stable visit they continue same dose; at second stable visit, reduce dose by 1 level

2. When stable condition with toxicity: toxicity is treated; reduce dose by 1 level

• Deteriorate: When worsening condition, increase dose by 1 or 2 levels but not >40mg/day

Dose tapering was done based on the participant's clinical condition.

Category "Missing Assessment" indicates participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=27 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=28 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
DBT: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 24 Improved	17 Participants	21 Participants
DBT: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 24 Unchanged	8 Participants	4 Participants
DBT: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 24 Deteriorate	0 Participants	0 Participants
DBT: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 24 Missing Assessment	2 Participants	3 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase.

Corticosteroids are first line treatment for sarcoidosis. Concerns of corticosteroid toxicity led to efforts to taper dose sooner. Participants were clinically evaluated at each visit by investigator and categorized by their condition; dose was tapered using algorithm to take them off prednisone using incremental doses of 40,30,20,10,7.5,5,2.5,0 mg, as explained with each category below.

• Improved: When condition improved, reduce dose by 1 level
• Unchanged:

1. When stable condition without toxicity: At first stable visit they continue same dose; at second stable visit, reduce dose by 1 level

2. When stable condition with toxicity: toxicity is treated; reduce dose by 1 level

• Deteriorate: When worsening condition, increase dose by 1 or 2 levels but not >40mg/day

Dose tapering was done based on the participant's clinical condition.

Category "Missing Assessment" indicates participants who had a missing assessment for this outcome measure.

Outcome measures

Measure	Acthar Gel in DBT Then Acthar Gel in OLE n=22 Participants Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.	Placebo in DBT Then Acthar Gel in OLE n=25 Participants Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the OLE phase.
OLE: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 48 Improved	15 Participants	19 Participants
OLE: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 48 Unchanged	5 Participants	5 Participants
OLE: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 48 Deteriorate	0 Participants	0 Participants
OLE: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 48 Missing Assessment	2 Participants	1 Participants

Adverse Events

DBT: Acthar Gel 80 U (1 mL)

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

DBT: Placebo

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

OLE: Acthar Gel 80 U (1 mL) [Received Acthar in DBT]

Serious events: 6 serious events

Other events: 14 other events

Deaths: 0 deaths

OLE: Acthar Gel 80 U (1 mL) [Received Placebo in DBT]

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	DBT: Acthar Gel 80 U (1 mL) n=27 participants at risk Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase.	DBT: Placebo n=28 participants at risk Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase.	OLE: Acthar Gel 80 U (1 mL) [Received Acthar in DBT] n=22 participants at risk Participants who received Acthar Gel in the DBT phase and opted to continue treatment in OLE phase, received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the OLE phase.	OLE: Acthar Gel 80 U (1 mL) [Received Placebo in DBT] n=25 participants at risk Participants who received Acthar Gel matching placebo in the DBT phase and opted to continue treatment in OLE phase, received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the OLE phase.
Eye disorders Uveitis	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Hepatobiliary disorders Cholelithiasis	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Influenza	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Diverticulitis	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Pelvic abscess	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Pneumonia	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Respiratory, thoracic and mediastinal disorders Asthma	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Investigations Haemoglobin decreased	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.

Other adverse events

Measure	DBT: Acthar Gel 80 U (1 mL) n=27 participants at risk Participants received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase.	DBT: Placebo n=28 participants at risk Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase.	OLE: Acthar Gel 80 U (1 mL) [Received Acthar in DBT] n=22 participants at risk Participants who received Acthar Gel in the DBT phase and opted to continue treatment in OLE phase, received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the OLE phase.	OLE: Acthar Gel 80 U (1 mL) [Received Placebo in DBT] n=25 participants at risk Participants who received Acthar Gel matching placebo in the DBT phase and opted to continue treatment in OLE phase, received Acthar Gel as a 1 mL injection under the skin, twice weekly, for 24 weeks in the OLE phase.
Eye disorders Dry eye	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Eye disorders Ocular hyperaemia	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Gastrointestinal disorders Abdominal pain	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	9.1% 2/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	8.0% 2/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Gastrointestinal disorders Diarrhoea	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	9.1% 2/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	12.0% 3/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Gastrointestinal disorders Nausea	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	13.6% 3/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
General disorders Chest discomfort	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	8.0% 2/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
General disorders Fatigue	14.8% 4/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	14.3% 4/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	9.1% 2/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	8.0% 2/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
General disorders Injection site bruising	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	17.9% 5/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	8.0% 2/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
General disorders Injection site swelling	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
General disorders Oedema peripheral	11.1% 3/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
General disorders Peripheral swelling	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Immune system disorders Sarcoidosis	11.1% 3/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Bronchitis	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	13.6% 3/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Nasopharyngitis	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	8.0% 2/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Oral candidiasis	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Pneumonia	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Upper respiratory tract infection	18.5% 5/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Infections and infestations Urinary tract infection	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Injury, poisoning and procedural complications Contusion	11.1% 3/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Investigations C-reactive protein increased	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	9.1% 2/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Investigations Weight increased	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Metabolism and nutrition disorders Diabetes mellitus	22.2% 6/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Metabolism and nutrition disorders Hyperglycaemia	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Metabolism and nutrition disorders Hyperlipidaemia	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Metabolism and nutrition disorders Hypophosphataemia	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Metabolism and nutrition disorders Increased appetite	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Metabolism and nutrition disorders Obesity	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	28.6% 8/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	9.1% 2/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	10.7% 3/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	10.7% 3/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	8.0% 2/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Musculoskeletal and connective tissue disorders Myalgia	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	9.1% 2/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Nervous system disorders Dizziness	11.1% 3/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Nervous system disorders Headache	14.8% 4/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	25.0% 7/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Psychiatric disorders Depression	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	9.1% 2/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Renal and urinary disorders Polyuria	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Respiratory, thoracic and mediastinal disorders Asthma	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	8.0% 2/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Respiratory, thoracic and mediastinal disorders Cough	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	17.9% 5/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	13.6% 3/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	8.0% 2/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	10.7% 3/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	9.1% 2/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.0% 1/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Skin and subcutaneous tissue disorders Rash	0.00% 0/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	4.5% 1/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Skin and subcutaneous tissue disorders Rash macular	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Skin and subcutaneous tissue disorders Skin lesion	3.7% 1/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	7.1% 2/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.
Vascular disorders Hypertension	7.4% 2/27 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	3.6% 1/28 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	0.00% 0/22 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.	8.0% 2/25 • From the signing of Informed Consent Form (ICF) to follow up visit, 4 weeks after the last dose of study drug (approximately 52 weeks for a participant) The safety population included all randomized participants who received at least 1 dose of IMP. The open-label safety population included participants who continued into the OLE phase and received at least one dose of IMP during the OLE phase. As prespecified in the protocol, Adverse Events were collected and reported separately for DBT and OLE phases.

Additional Information

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