Trial Outcomes & Findings for A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis (NCT NCT05084963)

NCT ID: NCT05084963

Last Updated: 2025-05-21

Results Overview

The change from baseline in histologic eosinophil count in each treatment group will be summarized as the mean and Standard Deviation (SD)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2025-05-21

Participant Flow

Participant milestones

Measure	Arm 1: IRL201104 4 mg IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Overall Study STARTED	12	12	12
Overall Study COMPLETED	12	12	11
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	Arm 1: IRL201104 4 mg IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis

Baseline characteristics by cohort

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104	Total n=36 Participants Total of all reporting groups
Age, Continuous	39 years n=5 Participants	42 years n=7 Participants	33 years n=5 Participants	38.5 years n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	11 participants n=5 Participants	13 participants n=7 Participants	12 participants n=5 Participants	36 participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Full Analysis Set

The change from baseline in histologic eosinophil count in each treatment group will be summarized as the mean and Standard Deviation (SD)

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=12 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=12 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean)	-9.2 eosinophil count per high power field Standard Deviation 87.95	-31.6 eosinophil count per high power field Standard Deviation 68.09	-7.8 eosinophil count per high power field Standard Deviation 104.02

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis performed on Full Analysis Set participants with non-missing DSQ data

The DSQ is used to measure the frequency and intensity of dysphagia. The DSQ scores can range from 0 to 84, with a lower score indicating less frequent or less severe dysphagia. The change from baseline in DSQ score in each treatment group will be summarized as the median, minimum, and maximum

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=10 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline.	-15.000 score on a scale Interval -26.923 to 0.0	-6.937 score on a scale Interval -18.092 to 5.846	-3.909 score on a scale Interval -40.923 to 5.409

SECONDARY outcome

Timeframe: 4 weeks

Population: Full Analysis Set

Percent of participants with a histologic eosinophil count of < 15 eos/hpf will be summarized for each treatment group

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=12 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=12 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4)	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Full Analysis Set

The percent change from baseline in peak intraepithelial eosinophil count in each treatment group will be summarized as the mean and SD

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=12 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=12 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf)	31.061 percent change Standard Deviation 83.858	-19.007 percent change Standard Deviation 39.716	44.306 percent change Standard Deviation 197.449

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety Analysis Set

Number of participants who had a TEAE

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Treatment Emergent Adverse Events (TEAE)	6 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety Analysis Set

Number of participants with treatment emergent clinically significant abnormal lab value.

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Safety Laboratory Data: Biochemistry Creatine Kinase	1 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry High-Density Lipoprotein	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Low-Density Lipoprotein	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Triglycerides	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Glucose	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Total Cholesterol	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Alanine aminotransferase	0 Participants	1 Participants	0 Participants
Safety Laboratory Data: Biochemistry Aspartate aminotransferase	0 Participants	1 Participants	0 Participants
Safety Laboratory Data: Biochemistry Total Bilirubin	0 Participants	1 Participants	0 Participants
Safety Laboratory Data: Biochemistry Indirect Bilirubin	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Sodium	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Total Protein	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Potassium	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Creatinine	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Chloride	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Blood Urea Nitrogen	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Carbon dioxide	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Calcium	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Alkaline phosphatase	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Uric acid	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Albumin	0 Participants	0 Participants	0 Participants
Safety Laboratory Data: Biochemistry Lactate dehydrogenase	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety Analysis Set

Number of participants with treatment emergent clinically significant abnormal lab value

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Safety Laboratory Data: Coagulation Activated partial thromboplastin time	0 Participants	1 Participants	0 Participants
Safety Laboratory Data: Coagulation Prothrombin time	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety Analysis Set

Number of participants with treatment emergent clinically significant abnormal value [Hemoglobin, Hematocrit, red blood cells count, white blood cell count, red cell indices, platelet count and white blood cell differential (neutrophil, lymphocyte, monocyte, eosinophil, and basophil)].

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Safety Laboratory Data: Hematology Panel	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety Analysis Set

Number of participants with treatment emergent clinically significant abnormal value (Color, Glucose, Red blood cells, Clarity, Blood, Hyaline and other casts, pH, Bilirubin, Bacteria, Specific gravity, Leukocyte esterase, Epithelial cells, Ketones, Nitrite, Crystals, Protein, White blood cells, Yeast).

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Safety Laboratory Data: Urinalysis Panel	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety Analysis Set

Number of participants with treatment emergent clinically significant abnormal value (Ventricular Rate, PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval).

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
12-Lead ECG	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety Analysis Set

Number of participants with treatment emergent clinically significant abnormal value [Body Systems: head, eyes, ears, nose and throat (HEENT); cardiovascular, respiratory, gastrointestinal, dermatological, musculoskeletal, nervous systems, lymph nodes and general appearance].

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Physical Exam	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety Analysis Set

Number of participants with treatment emergent clinically significant abnormal value (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature).

Outcome measures

Measure	Arm 1: IRL201104 4 mg n=11 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 Participants IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 Participants Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Vital Signs	0 Participants	0 Participants	0 Participants

Adverse Events

Arm 1: IRL201104 4 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm 2: IRL201104 8 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Arm 3: Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1: IRL201104 4 mg n=11 participants at risk IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 2: IRL201104 8 mg n=13 participants at risk IRL201104 IV on Days 0, 7, and 14 IRL201104: lyophilised powder for reconstitution for IV dosing	Arm 3: Placebo n=12 participants at risk Placebo IV on Days 0, 7, and 14 Placebo: Matching placebo for IRL201104
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	16.7% 2/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Gastrointestinal disorders Constipation	18.2% 2/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Gastrointestinal disorders Nausea	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	25.0% 3/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Gastrointestinal disorders Abdominal discomfort	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Gastrointestinal disorders Abdominal distension	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Gastrointestinal disorders Diarrhoea	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Gastrointestinal disorders Vomiting	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Nervous system disorders Headache	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	16.7% 2/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Nervous system disorders Presyncope	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Nervous system disorders Dizziness	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Nervous system disorders Dysgeusia	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Nervous system disorders Tremor	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
General disorders Fatigue	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	16.7% 2/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
General disorders Chest discomfort	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
General disorders Infusion site pain	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
General disorders Non-cardiac chest pain	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Infections and infestations COVID-19	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Infections and infestations Ear infection	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Infections and infestations Upper respiratory tract infection	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Infections and infestations Urinary tract infection	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	16.7% 2/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Metabolism and nutrition disorders Gout	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Psychiatric disorders Anxiety	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Psychiatric disorders Insomnia	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Psychiatric disorders Sleep disorder	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Skin and subcutaneous tissue disorders Rash	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Ear and labyrinth disorders Tinnitus	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Ear and labyrinth disorders Vertigo	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	8.3% 1/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Investigations Alanine aminotransferase increased	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Investigations Aspartate aminotransferase increased	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Investigations Blood bilirubin increased	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Investigations Blood creatinine phosphatase increased	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Congenital, familial and genetic disorders Type IIb hyperlipidaemia	9.1% 1/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Immune system disorders Seasonal allergy	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/11 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	7.7% 1/13 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.	0.00% 0/12 • From first dose to week 8 Safety Analysis Set - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations will consider participants according to the actual treatment they received.

Additional Information

Chief Medical Officer

Revolo Biotherapeutics

Phone: (888) 599-7431

Email: clinicaltrials@revolobio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place