Trial Outcomes & Findings for Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN) (NCT NCT04706793)

NCT ID: NCT04706793

Last Updated: 2023-10-16

Results Overview

Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 42 participants
• Primary outcome timeframe: Week 40 of APD334-308
• Results posted on: 2023-10-16

Participant Flow

Participant milestones

Measure	Placebo Comparator: Placebo Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Treatment STARTED	14	28
Treatment COMPLETED	4	18
Treatment NOT COMPLETED	10	10
Follow-up STARTED	14	28
Follow-up COMPLETED	4	18
Follow-up NOT COMPLETED	10	10

Reasons for withdrawal

Measure	Placebo Comparator: Placebo Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Treatment Disease worsening	10	10
Follow-up Lack of Efficacy	1	0
Follow-up Disease worsening	8	10
Follow-up Adverse Event	1	0

Baseline Characteristics

Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)

Baseline characteristics by cohort

Measure	Placebo Comparator: Placebo n=14 Participants Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg n=28 Participants Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308	Total n=42 Participants Total of all reporting groups
Age, Continuous	44.2 Years STANDARD_DEVIATION 14.12 • n=5 Participants	43.9 Years STANDARD_DEVIATION 14.29 • n=7 Participants	44.0 Years STANDARD_DEVIATION 14.06 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	18 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	28 Participants n=7 Participants	42 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	14 Participants n=5 Participants	28 Participants n=7 Participants	42 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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

PRIMARY outcome

Timeframe: Week 40 of APD334-308

Population: Full Analysis Set Population (All randomized participants who received at least 1 dose of study intervention). Only those participants with data available at the specified time points were analyzed. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure".

Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

Outcome measures

Measure	Placebo Comparator: Placebo n=14 Participants Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg n=28 Participants Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308	7.1 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 40 of APD334-308

Population: Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure".

Endoscopic improvement was defined as an ES <=1 (excluding friability) at Week 40 of APD334-308 compared with Week 12 of APD334-302. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease.

Outcome measures

Measure	Placebo Comparator: Placebo n=14 Participants Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg n=28 Participants Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308	7.1 Percentage of participants	35.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 40 of APD334-308

Population: Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed.

Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.

Outcome measures

Measure	Placebo Comparator: Placebo n=14 Participants Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg n=28 Participants Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308	7.1 Percentage of participants	39.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 40 of APD334-308

Population: Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed.

Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease.

Outcome measures

Measure	Placebo Comparator: Placebo n=14 Participants Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg n=28 Participants Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308	7.1 Percentage of participants	28.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 40 of APD334-308

Population: Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed.

Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

Outcome measures

Measure	Placebo Comparator: Placebo n=14 Participants Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg n=28 Participants Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry	7.1 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 40 of APD334-308

Population: Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed.

Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. A subject with sustained clinical remission is defined as someone who achieved clinical remission at both Week 12 of APD334-302 and Week 40 of APD334-308.

Outcome measures

Measure	Placebo Comparator: Placebo n=14 Participants Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg n=28 Participants Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Percentage of Participants Achieving Sustained Clinical Remission	0 Percentage of participants	7.1 Percentage of participants

Adverse Events

Placebo Comparator: Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Experimental: Etrasimod 2 mg

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Comparator: Placebo n=14 participants at risk Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg n=28 participants at risk Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Infections and infestations COVID-19	0.00% 0/14 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Colitis ulcerative	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.

Other adverse events

Measure	Placebo Comparator: Placebo n=14 participants at risk Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308	Experimental: Etrasimod 2 mg n=28 participants at risk Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308
Gastrointestinal disorders Colitis ulcerative	7.1% 1/14 • Number of events 2 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	7.1% 2/28 • Number of events 2 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Stomatitis	7.1% 1/14 • Number of events 2 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Pyrexia	14.3% 2/14 • Number of events 2 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	10.7% 3/28 • Number of events 3 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Malaise	0.00% 0/14 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	10.7% 3/28 • Number of events 4 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
General disorders Vaccination site pain	0.00% 0/14 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	7.1% 2/28 • Number of events 3 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Infected dermal cyst	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Sinusitis	7.1% 1/14 • Number of events 3 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Tonsillitis	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	14.3% 2/14 • Number of events 4 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	14.3% 4/28 • Number of events 6 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Cervicobrachial syndrome	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Eye disorders Cataract	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Contusion	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Anaemia	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Investigations Glucose urine present	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Psychiatric disorders Depression	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	7.1% 1/14 • Number of events 1 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308). Safety set population included all randomized participants who received at least 1 dose of study intervention.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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