Trial Outcomes & Findings for PRV-015 in Gluten-free Diet Non-responsive Celiac Disease (NCT NCT04424927)

NCT ID: NCT04424927

Last Updated: 2025-10-20

Results Overview

The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Abdominal Symptoms domain included abdominal cramping, abdominal pain, bloating and gas. Total score for abdominal symptoms domain range from 0 to 40. Higher scores indicated worse outcome. Baseline abdominal symptoms domain score was defined as the average of the daily scores for the last week of the placebo run-in period.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 388 participants
• Primary outcome timeframe: Baseline (average of Day -7 to Day -1) up to Week 24
• Results posted on: 2025-10-20

Participant Flow

The study was conducted at 39 centers in 4 countries. A total of 648 participants were screened between 24 August 2020 and 16 January 2024, of which 255 participants were screen failures and 5 participants discontinued before run-in period. Screen failures were mainly due to not meeting eligibility criteria.

A total of 388 participants entered the single-blind placebo run-in period and among them, 1 participant never received treatment and was not started after signing the ICF, 9 participants discontinued during run-in or were not dosed, and 27 participants were considered run-in failures. Another 126 participants were considered randomization failures. A total of 226 participants were enrolled and randomized in the study.

Participant milestones

Measure	Single-blind: Placebo Participants received placebo subcutaneous (SC) injection every 2 weeks (q2w) in single-blind placebo run-in period for 4 weeks.	Double-blind: Placebo Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 100 mg Participants received PRV-015 100 milligram (mg) SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 300 mg Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 600 mg Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Single-blind Period (4 Weeks) STARTED	388	0	0	0	0
Single-blind Period (4 Weeks) Received Treatment	387	0	0	0	0
Single-blind Period (4 Weeks) COMPLETED	352	0	0	0	0
Single-blind Period (4 Weeks) NOT COMPLETED	36	0	0	0	0
Double-blind Period (24 Weeks) STARTED	0	57	56	57	56
Double-blind Period (24 Weeks) Received Treatment	0	57	56	57	54
Double-blind Period (24 Weeks) COMPLETED	0	51	47	51	49
Double-blind Period (24 Weeks) NOT COMPLETED	0	6	9	6	7

Reasons for withdrawal

Measure	Single-blind: Placebo Participants received placebo subcutaneous (SC) injection every 2 weeks (q2w) in single-blind placebo run-in period for 4 weeks.	Double-blind: Placebo Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 100 mg Participants received PRV-015 100 milligram (mg) SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 300 mg Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 600 mg Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Single-blind Period (4 Weeks) Not treated	1	0	0	0	0
Single-blind Period (4 Weeks) Run-in failure	27	0	0	0	0
Single-blind Period (4 Weeks) Withdrawal by Subject	7	0	0	0	0
Single-blind Period (4 Weeks) Investigator or sponsor judgement	1	0	0	0	0
Double-blind Period (24 Weeks) Lost to Follow-up	0	1	1	0	0
Double-blind Period (24 Weeks) Withdrawal by Subject	0	3	5	5	6
Double-blind Period (24 Weeks) Investigator or Sponsor judgement	0	1	0	0	1
Double-blind Period (24 Weeks) Other	0	1	3	1	0

Baseline Characteristics

Baseline measure data reported for each study period separately.

Baseline characteristics by cohort

Measure	Single-blind: Placebo n=387 Participants Participants received placebo SC injection q2w in single-blind placebo run-in period for 4 weeks.	Double-blind: Placebo n=57 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 100 mg n=56 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 300 mg n=57 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 600 mg n=56 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.	Total n=613 Participants Total of all reporting groups
Age, Continuous Single-blind period	41.2 years STANDARD_DEVIATION 13.8 • n=387 Participants • Baseline measure data reported for each study period separately.	—	—	—	—	41.2 years STANDARD_DEVIATION 13.8 • n=387 Participants • Baseline measure data reported for each study period separately.
Age, Continuous Double-blind period	—	41.0 years STANDARD_DEVIATION 14.53 • n=57 Participants • Baseline measure data reported for each study period separately.	41.9 years STANDARD_DEVIATION 14.82 • n=56 Participants • Baseline measure data reported for each study period separately.	39.0 years STANDARD_DEVIATION 12.25 • n=57 Participants • Baseline measure data reported for each study period separately.	37.9 years STANDARD_DEVIATION 12.58 • n=56 Participants • Baseline measure data reported for each study period separately.	39.9 years STANDARD_DEVIATION 13.59 • n=226 Participants • Baseline measure data reported for each study period separately.
Sex: Female, Male Single-blind period · Female	313 Participants n=387 Participants • Baseline measure data reported for each study period separately.	0 Participants Baseline measure data reported for each study period separately.	0 Participants Baseline measure data reported for each study period separately.	0 Participants Baseline measure data reported for each study period separately.	0 Participants Baseline measure data reported for each study period separately.	313 Participants n=387 Participants • Baseline measure data reported for each study period separately.
Sex: Female, Male Single-blind period · Male	74 Participants n=387 Participants • Baseline measure data reported for each study period separately.	0 Participants Baseline measure data reported for each study period separately.	0 Participants Baseline measure data reported for each study period separately.	0 Participants Baseline measure data reported for each study period separately.	0 Participants Baseline measure data reported for each study period separately.	74 Participants n=387 Participants • Baseline measure data reported for each study period separately.
Sex: Female, Male Double-blind period · Female	0 Participants Baseline measure data reported for each study period separately.	53 Participants n=57 Participants • Baseline measure data reported for each study period separately.	38 Participants n=56 Participants • Baseline measure data reported for each study period separately.	50 Participants n=57 Participants • Baseline measure data reported for each study period separately.	45 Participants n=56 Participants • Baseline measure data reported for each study period separately.	186 Participants n=226 Participants • Baseline measure data reported for each study period separately.
Sex: Female, Male Double-blind period · Male	0 Participants Baseline measure data reported for each study period separately.	4 Participants n=57 Participants • Baseline measure data reported for each study period separately.	18 Participants n=56 Participants • Baseline measure data reported for each study period separately.	7 Participants n=57 Participants • Baseline measure data reported for each study period separately.	11 Participants n=56 Participants • Baseline measure data reported for each study period separately.	40 Participants n=226 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Single-blind period · Black or African American	4 Participants n=387 Participants • Baseline measure data reported for each study period separately.	—	—	—	—	4 Participants n=387 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Single-blind period · White	375 Participants n=387 Participants • Baseline measure data reported for each study period separately.	—	—	—	—	375 Participants n=387 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Single-blind period · Asian	1 Participants n=387 Participants • Baseline measure data reported for each study period separately.	—	—	—	—	1 Participants n=387 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Single-blind period · American Indian or Alaska Native	2 Participants n=387 Participants • Baseline measure data reported for each study period separately.	—	—	—	—	2 Participants n=387 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Single-blind period · Not Reported	3 Participants n=387 Participants • Baseline measure data reported for each study period separately.	—	—	—	—	3 Participants n=387 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Single-blind period · Unknown	1 Participants n=387 Participants • Baseline measure data reported for each study period separately.	—	—	—	—	1 Participants n=387 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Single-blind period · Multiple	1 Participants n=387 Participants • Baseline measure data reported for each study period separately.	—	—	—	—	1 Participants n=387 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Double-blind period · Black or African American	—	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	1 Participants n=56 Participants • Baseline measure data reported for each study period separately.	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	0 Participants n=56 Participants • Baseline measure data reported for each study period separately.	1 Participants n=226 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Double-blind period · White	—	57 Participants n=57 Participants • Baseline measure data reported for each study period separately.	55 Participants n=56 Participants • Baseline measure data reported for each study period separately.	56 Participants n=57 Participants • Baseline measure data reported for each study period separately.	53 Participants n=56 Participants • Baseline measure data reported for each study period separately.	221 Participants n=226 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Double-blind period · Asian	—	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	0 Participants n=56 Participants • Baseline measure data reported for each study period separately.	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	0 Participants n=56 Participants • Baseline measure data reported for each study period separately.	0 Participants n=226 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Double-blind period · American Indian or Alaska Native	—	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	0 Participants n=56 Participants • Baseline measure data reported for each study period separately.	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	0 Participants n=56 Participants • Baseline measure data reported for each study period separately.	0 Participants n=226 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Double-blind period · Not Reported	—	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	0 Participants n=56 Participants • Baseline measure data reported for each study period separately.	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	2 Participants n=56 Participants • Baseline measure data reported for each study period separately.	2 Participants n=226 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Double-blind period · Unknown	—	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	0 Participants n=56 Participants • Baseline measure data reported for each study period separately.	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	1 Participants n=56 Participants • Baseline measure data reported for each study period separately.	1 Participants n=226 Participants • Baseline measure data reported for each study period separately.
Race/Ethnicity, Customized Double-blind period · Multiple	—	0 Participants n=57 Participants • Baseline measure data reported for each study period separately.	0 Participants n=56 Participants • Baseline measure data reported for each study period separately.	1 Participants n=57 Participants • Baseline measure data reported for each study period separately.	0 Participants n=56 Participants • Baseline measure data reported for each study period separately.	1 Participants n=226 Participants • Baseline measure data reported for each study period separately.
Celiac Disease Patient Reported Outcome (CeD PRO) Abdominal Symptoms Domain Score Single-blind period · Score: <3	—	—	—	—	—	0 Participants Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.
Celiac Disease Patient Reported Outcome (CeD PRO) Abdominal Symptoms Domain Score Single-blind period · Score: >=3	—	—	—	—	—	0 Participants Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.
Celiac Disease Patient Reported Outcome (CeD PRO) Abdominal Symptoms Domain Score Double-blind period · Score: <3	—	13 Participants n=57 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	13 Participants n=56 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	13 Participants n=57 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	13 Participants n=56 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	52 Participants n=226 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.
Celiac Disease Patient Reported Outcome (CeD PRO) Abdominal Symptoms Domain Score Double-blind period · Score: >=3	—	44 Participants n=57 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	43 Participants n=56 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	44 Participants n=57 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	43 Participants n=56 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	174 Participants n=226 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.
Number of Participants for Stratification Factor Villous Height-to-Crypt Depth Ratio (VH:CD) Single-blind period · Ratio: <2	—	—	—	—	—	0 Participants Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.
Number of Participants for Stratification Factor Villous Height-to-Crypt Depth Ratio (VH:CD) Single-blind period · Ratio: >=2	—	—	—	—	—	0 Participants Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.
Number of Participants for Stratification Factor Villous Height-to-Crypt Depth Ratio (VH:CD) Double-blind period · Ratio: <2	—	37 Participants n=57 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	37 Participants n=56 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	37 Participants n=57 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	36 Participants n=56 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	147 Participants n=226 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.
Number of Participants for Stratification Factor Villous Height-to-Crypt Depth Ratio (VH:CD) Double-blind period · Ratio: >=2	—	20 Participants n=57 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	19 Participants n=56 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	20 Participants n=57 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	20 Participants n=56 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.	79 Participants n=226 Participants • Baseline measure data reported for each study period separately. Analysis was not performed during the single-blind placebo period for this measurement as it is specific to the double-blind periods and IMP per the protocol, and the single-blind number analyzed is 0.

PRIMARY outcome

Timeframe: Baseline (average of Day -7 to Day -1) up to Week 24

Population: The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported.

The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Abdominal Symptoms domain included abdominal cramping, abdominal pain, bloating and gas. Total score for abdominal symptoms domain range from 0 to 40. Higher scores indicated worse outcome. Baseline abdominal symptoms domain score was defined as the average of the daily scores for the last week of the placebo run-in period.

Outcome measures

Measure	Placebo n=56 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=55 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=56 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg n=52 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24	-1.32 score on a scale Interval -1.66 to -0.98	-1.28 score on a scale Interval -1.62 to -0.94	-1.21 score on a scale Interval -1.55 to -0.88	-1.28 score on a scale Interval -1.63 to -0.93

SECONDARY outcome

Timeframe: Baseline (average of Day -7 to Day -1) up to Week 24

Population: The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported.

The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Diarrhea and loose stool domain included diarrhea and loose stool. Total score for diarrhea and loose stool domain range from 0 to 20. Higher scores indicated worse outcome. Baseline diarrhea and loose stool domain score was defined as the average of the daily scores for the last week of the placebo run-in period.

Outcome measures

Measure	Placebo n=56 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=55 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=56 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg n=52 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24	-0.77 score on a scale Interval -1.15 to -0.4	-0.66 score on a scale Interval -1.04 to -0.28	-1.02 score on a scale Interval -1.39 to -0.64	-1.07 score on a scale Interval -1.46 to -0.68

SECONDARY outcome

Timeframe: Baseline (average of Day -7 to Day -1) up to Week 24

Population: The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported.

The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Total GI domain included abdominal symptoms domain, diarrhea, loose stool and nausea. Total GI score range from 0 to 70. Higher scores indicated worse outcome. Baseline GI score was defined as the average of the daily scores for the last week of the placebo run-in period.

Outcome measures

Measure	Placebo n=56 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=55 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=56 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg n=52 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24	-0.89 score on a scale Interval -1.15 to -0.63	-0.84 score on a scale Interval -1.1 to -0.57	-0.88 score on a scale Interval -1.14 to -0.62	-1.05 score on a scale Interval -1.32 to -0.78

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and Week 24 are reported.

The small intestinal mucosal inflammation was measured by IEL density using immunohistochemistry. Baseline was defined as IEL density from the esophagogastroduodenoscopy biopsy conducted during the run-in period.

Outcome measures

Measure	Placebo n=51 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=49 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=51 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg n=48 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24	-0.39 cells/100 epithelial cells Interval -3.82 to 3.03	1.54 cells/100 epithelial cells Interval -1.99 to 5.07	-4.11 cells/100 epithelial cells Interval -7.56 to -0.66	-4.53 cells/100 epithelial cells Interval -8.13 to -0.93

SECONDARY outcome

Timeframe: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

Population: The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.

An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs included severe opportunistic infections and hypersensitivity reactions of at least moderate severity. A TEAE was defined as an AE that occurred from the first dose of post-randomization study drug administration through the end of the study.

Outcome measures

Measure	Placebo n=57 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=56 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=57 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg n=54 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs) Any TEAE	34 Participants	34 Participants	36 Participants	29 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs) TEAE leading to study treatment discontinuation	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs) Treatment-emergent SAE	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs) Treatment-emergent AESI	2 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

Population: The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected are reported.

Blood samples were collected to determine the hematology laboratory important changes. CHG= Change from baseline hemoglobin.

Outcome measures

Measure	Placebo n=57 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=56 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=57 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg n=53 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Number of Participants With Potentially Clinically Important Changes in Hematology Hemoglobin: CHG <=-20 g/L	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Potentially Clinically Important Changes in Hematology Neutrophils: <1 10^9/L	2 Participants	1 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

Population: The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected are reported.

Blood samples were collected to determine the clinical chemistry laboratory important changes. ULN= Upper limit of normal, mmol/L= millimoles per liter and mcmol/L= micromoles per liter.

Outcome measures

Measure	Placebo n=57 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=56 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=57 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg n=53 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry Alanine Aminotransferase: >=3x ULN	1 Participants	4 Participants	1 Participants	2 Participants
Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry Aspartate Aminotransferase: >=3x ULN	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry Chloride: >125 mmol/L	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry Creatinine: >=132 mcmol/L	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry Potassium: >6 mmol/L	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry Sodium: <125 mmol/L	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

Population: The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected for each specific parameter are reported.

Urine samples were collected to determine the important changes in urine. TNTC= Too numerous to count, LPF= Low power field and HPF= High power field.

Outcome measures

Measure	Placebo n=57 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=56 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=57 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg n=53 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Number of Participants With Potentially Clinically Important Changes in Urinalysis Ketones: 3+	1 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Potentially Clinically Important Changes in Urinalysis Bacteria: Present	54 Participants	51 Participants	55 Participants	47 Participants
Number of Participants With Potentially Clinically Important Changes in Urinalysis Crystals: Present	3 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With Potentially Clinically Important Changes in Urinalysis Erythrocytes (/HPF): Many/TNTC	1 Participants	0 Participants	4 Participants	3 Participants
Number of Participants With Potentially Clinically Important Changes in Urinalysis Glucose: 3+/4+	1 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Important Changes in Urinalysis Hyaline Casts (/HPF): Few/Moderate/Many	3 Participants	2 Participants	3 Participants	0 Participants
Number of Participants With Potentially Clinically Important Changes in Urinalysis Hyaline Casts (/LPF): Few/Moderate/Many	—	1 Participants	1 Participants	—
Number of Participants With Potentially Clinically Important Changes in Urinalysis Leukocyte Esterase: 3+/4+	19 Participants	12 Participants	16 Participants	15 Participants
Number of Participants With Potentially Clinically Important Changes in Urinalysis Leukocytes (/HPF): Many/TNTC	11 Participants	3 Participants	9 Participants	7 Participants
Number of Participants With Potentially Clinically Important Changes in Urinalysis Nitrite: Positive	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Potentially Clinically Important Changes in Urinalysis Squamous Epithelial Cells (/HPF): Many/TNTC	6 Participants	0 Participants	6 Participants	8 Participants

SECONDARY outcome

Timeframe: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days

Population: The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.

Participant's vital signs and body weight were examined to determine the important changes. Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. mmHg= millimeters of mercury, DFB= Decrease from baseline and IFB= Increase from baseline.

Outcome measures

Measure	Placebo n=57 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=56 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=57 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg n=54 Participants Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight SBP: <=95 mmHg and DFB >=20 mmHg	5 Participants	2 Participants	6 Participants	1 Participants
Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight SBP: >=160 mmHg and IFB >=20 mmHg	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight DBP: >=110 mmHg and IFB >=10 mmHg	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight Heart Rate: <=50 bpm and DFB >=20 bpm	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight Heart Rate: >=120 bpm and IFB >=20 bpm	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight Body weight: >=5% DFB	8 Participants	11 Participants	9 Participants	7 Participants
Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight Body weight: >=5% IFB	9 Participants	8 Participants	13 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 12, 22, 24 and 28

Population: The Immunogenicity analysis set included participants who were randomized, dosed, and had at least 1 evaluable immunogenicity assessment. Only participants with data collected at specific time point are reported.

Blood samples were collected to determine the presence of anti-drug antibodies by immunoassay.

Outcome measures

Measure	Placebo n=53 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=56 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=53 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Number of Participants With Anti-PRV-015 Antibodies Baseline	3 Participants	8 Participants	7 Participants	—
Number of Participants With Anti-PRV-015 Antibodies Week 2	8 Participants	9 Participants	9 Participants	—
Number of Participants With Anti-PRV-015 Antibodies Week 4	5 Participants	6 Participants	5 Participants	—
Number of Participants With Anti-PRV-015 Antibodies Week 12	4 Participants	5 Participants	4 Participants	—
Number of Participants With Anti-PRV-015 Antibodies Week 22	4 Participants	4 Participants	2 Participants	—
Number of Participants With Anti-PRV-015 Antibodies Week 24	4 Participants	3 Participants	2 Participants	—
Number of Participants With Anti-PRV-015 Antibodies Week 28	4 Participants	3 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1 and Weeks 2, 4, 8, 12, 16, 20, 22, 24 and 28

Population: The Pharmacokinetic (PK) analysis set included participants who were randomized, dosed, and had at least 1 post-dose evaluable PK assessment. Only participants with data collected at specific time point are reported. Participants were not analyzed at pre-dose on Day 1 as the study drug was not administered. Hence, no data collected.

Blood samples were collected at specified timepoints to determine the Cmin.

Outcome measures

Measure	Placebo n=46 Participants Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 100 mg n=53 Participants Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 300 mg n=46 Participants Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	PRV-015 600 mg Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Minimum Serum Concentrations (Cmin) of PRV-015 Week 4	15140 nanogram per milliliter Geometric Coefficient of Variation 42.8	51190 nanogram per milliliter Geometric Coefficient of Variation 42.1	98420 nanogram per milliliter Geometric Coefficient of Variation 49.4	—
Minimum Serum Concentrations (Cmin) of PRV-015 Week 2	8778 nanogram per milliliter Geometric Coefficient of Variation 74.1	27820 nanogram per milliliter Geometric Coefficient of Variation 39.8	66400 nanogram per milliliter Geometric Coefficient of Variation 46.1	—
Minimum Serum Concentrations (Cmin) of PRV-015 Week 8	21790 nanogram per milliliter Geometric Coefficient of Variation 46.4	61990 nanogram per milliliter Geometric Coefficient of Variation 66.5	142600 nanogram per milliliter Geometric Coefficient of Variation 43.7	—
Minimum Serum Concentrations (Cmin) of PRV-015 Week 12	23630 nanogram per milliliter Geometric Coefficient of Variation 46.8	73150 nanogram per milliliter Geometric Coefficient of Variation 56.5	168300 nanogram per milliliter Geometric Coefficient of Variation 37.9	—
Minimum Serum Concentrations (Cmin) of PRV-015 Week 16	22960 nanogram per milliliter Geometric Coefficient of Variation 46.7	75830 nanogram per milliliter Geometric Coefficient of Variation 65.1	166700 nanogram per milliliter Geometric Coefficient of Variation 44.9	—
Minimum Serum Concentrations (Cmin) of PRV-015 Week 20	27000 nanogram per milliliter Geometric Coefficient of Variation 42.5	74110 nanogram per milliliter Geometric Coefficient of Variation 67.8	186400 nanogram per milliliter Geometric Coefficient of Variation 51.2	—
Minimum Serum Concentrations (Cmin) of PRV-015 Week 22	25410 nanogram per milliliter Geometric Coefficient of Variation 36.2	73120 nanogram per milliliter Geometric Coefficient of Variation 64.2	181000 nanogram per milliliter Geometric Coefficient of Variation 55.6	—
Minimum Serum Concentrations (Cmin) of PRV-015 Week 24	26680 nanogram per milliliter Geometric Coefficient of Variation 40.3	72400 nanogram per milliliter Geometric Coefficient of Variation 49.6	160500 nanogram per milliliter Geometric Coefficient of Variation 47.5	—
Minimum Serum Concentrations (Cmin) of PRV-015 Week 28	10210 nanogram per milliliter Geometric Coefficient of Variation 58.0	32810 nanogram per milliliter Geometric Coefficient of Variation 80.0	69370 nanogram per milliliter Geometric Coefficient of Variation 78.3	—

Adverse Events

Single-blind: Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Double-blind: Placebo

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Double-blind: PRV-015 100 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Double-blind: PRV-015 300 mg

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Double-blind: PRV-015 600 mg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single-blind: Placebo n=387 participants at risk Participants received placebo SC injection q2w in single-blind placebo run-in period for 4 weeks.	Double-blind: Placebo n=57 participants at risk Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 100 mg n=56 participants at risk Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 300 mg n=57 participants at risk Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 600 mg n=54 participants at risk Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Nervous system disorders Presyncope	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/56 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.9% 1/54 • Number of events 1 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Injury, poisoning and procedural complications Pelvic Fracture	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.8% 1/57 • Number of events 1 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/56 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/54 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Metabolism and nutrition disorders Gluten Sensitivity	0.26% 1/387 • Number of events 1 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/56 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/54 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Gastrointestinal disorders Intussusception	0.26% 1/387 • Number of events 1 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/56 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/54 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.

Other adverse events

Measure	Single-blind: Placebo n=387 participants at risk Participants received placebo SC injection q2w in single-blind placebo run-in period for 4 weeks.	Double-blind: Placebo n=57 participants at risk Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 100 mg n=56 participants at risk Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 300 mg n=57 participants at risk Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.	Double-blind: PRV-015 600 mg n=54 participants at risk Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
Infections and infestations Covid-19	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.3% 3/57 • Number of events 3 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	8.9% 5/56 • Number of events 5 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	14.0% 8/57 • Number of events 8 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	9.3% 5/54 • Number of events 5 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	8.8% 5/57 • Number of events 6 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.4% 3/56 • Number of events 5 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	7.0% 4/57 • Number of events 4 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	7.4% 4/54 • Number of events 4 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Nervous system disorders Headache	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.8% 1/57 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	7.1% 4/56 • Number of events 4 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	8.8% 5/57 • Number of events 5 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	3.7% 2/54 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Nervous system disorders Migraine	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	7.0% 4/57 • Number of events 4 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	3.6% 2/56 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.8% 1/57 • Number of events 1 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.9% 1/54 • Number of events 1 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Gastrointestinal disorders Abdominal Distension	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.8% 1/57 • Number of events 1 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.4% 3/56 • Number of events 4 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	3.7% 2/54 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Gastrointestinal disorders Abdominal Pain	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.3% 3/57 • Number of events 3 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.4% 3/56 • Number of events 3 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	7.4% 4/54 • Number of events 4 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Gastrointestinal disorders Diarrhoea	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	10.5% 6/57 • Number of events 7 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.8% 1/56 • Number of events 1 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	7.0% 4/57 • Number of events 6 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	7.4% 4/54 • Number of events 4 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Gastrointestinal disorders Nausea	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.8% 1/57 • Number of events 1 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	3.6% 2/56 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	8.8% 5/57 • Number of events 5 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.6% 3/54 • Number of events 3 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Skin and subcutaneous tissue disorders Rash	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	7.0% 4/57 • Number of events 4 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/56 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.3% 3/57 • Number of events 3 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.9% 1/54 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	3.5% 2/57 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.4% 3/56 • Number of events 3 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	3.7% 2/54 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
General disorders Injection Site Bruising	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/57 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	0.00% 0/56 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	3.5% 2/57 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.6% 3/54 • Number of events 3 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
General disorders Injection Site Erythema	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	3.5% 2/57 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.4% 3/56 • Number of events 8 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.3% 3/57 • Number of events 6 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	3.7% 2/54 • Number of events 7 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
General disorders Injection Site Reaction	0.00% 0/387 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	1.8% 1/57 • Number of events 2 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.4% 3/56 • Number of events 4 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.3% 3/57 • Number of events 6 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.	5.6% 3/54 • Number of events 9 • Single-blind Period: From first dose of study drug administration (Day 1) up to 28 days. Double-blind Period: From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.

Additional Information

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• Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
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