Trial Outcomes & Findings for A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee (NCT NCT03956550)
NCT ID: NCT03956550
Last Updated: 2021-07-01
Results Overview
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
TERMINATED
PHASE2
259 participants
Baseline to Week 12
2021-07-01
Participant Flow
The study was conducted in 5 countries and 12 sites participated in enrollment. It consisted of screening period up to 30 days, followed by a 12-week randomized, double-blind, placebo-controlled treatment period, a 24-week follow-up period, and end-of-study phone call approximately 52 weeks after first dose. Study was terminated after all participants completed the week 36 visits.
A total of 259 participants were randomized in 1:1:1 ratio to receive REGN5069 at 100 mg IV Q4W, REGN5069 at 1000 mg IV Q4W, or matching placebo Q4W. Participants were to receive 3 fixed-dose IV infusions at baseline, week 4, and week 8. 171 participants were randomized to receive REGN5069 (86 participants in the 100 mg Q4W group and 85 in the 1000 mg Q4W group) and 88 were randomized to receive placebo.
Participant milestones
| Measure |
Placebo
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Overall Study
STARTED
|
88
|
86
|
85
|
|
Overall Study
COMPLETED
|
18
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
70
|
72
|
70
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Overall Study
Sponsor decision
|
65
|
66
|
64
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
6
|
Baseline Characteristics
Here 'n' = number of evaluable participants at this time interval
Baseline characteristics by cohort
| Measure |
Placebo
n=88 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=86 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=85 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.5 Years
STANDARD_DEVIATION 8.27 • n=88 Participants
|
63.9 Years
STANDARD_DEVIATION 7.39 • n=86 Participants
|
64.7 Years
STANDARD_DEVIATION 8.30 • n=85 Participants
|
64.0 Years
STANDARD_DEVIATION 7.98 • n=259 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=88 Participants
|
74 Participants
n=86 Participants
|
68 Participants
n=85 Participants
|
206 Participants
n=259 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=88 Participants
|
12 Participants
n=86 Participants
|
17 Participants
n=85 Participants
|
53 Participants
n=259 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=88 Participants
|
1 Participants
n=86 Participants
|
2 Participants
n=85 Participants
|
7 Participants
n=259 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=88 Participants
|
85 Participants
n=86 Participants
|
83 Participants
n=85 Participants
|
252 Participants
n=259 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=88 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=259 Participants
|
|
Race/Ethnicity, Customized
White
|
83 Participants
n=88 Participants
|
85 Participants
n=86 Participants
|
81 Participants
n=85 Participants
|
249 Participants
n=259 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=88 Participants
|
1 Participants
n=86 Participants
|
4 Participants
n=85 Participants
|
10 Participants
n=259 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=88 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=259 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=88 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=259 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=88 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=259 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=88 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=259 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=88 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=259 Participants
|
|
Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score
|
6.68 Scores on a scale
STANDARD_DEVIATION 1.257 • n=87 Participants • Here 'n' = number of evaluable participants at this time interval
|
6.24 Scores on a scale
STANDARD_DEVIATION 1.203 • n=86 Participants • Here 'n' = number of evaluable participants at this time interval
|
6.47 Scores on a scale
STANDARD_DEVIATION 1.150 • n=85 Participants • Here 'n' = number of evaluable participants at this time interval
|
6.36 Scores on a scale
STANDARD_DEVIATION 1.179 • n=258 Participants • Here 'n' = number of evaluable participants at this time interval
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set population (FAS): included all randomized participants; Here 'n' = number of evaluable participants at the specific time point.
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=80 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=82 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
|
-2.09 Scores on a scale
Standard Error 0.188
|
-2.37 Scores on a scale
Standard Error 0.191
|
-1.98 Scores on a scale
Standard Error 0.190
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set population (FAS): included all randomized participants; Here "number analyzed" = number of evaluable participants at this time interval
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=80 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=82 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Change From Baseline to Week 12 in WOMAC Total Score
|
-1.83 Scores on a scale
Standard Error 0.177
|
-2.15 Scores on a scale
Standard Error 0.179
|
-1.81 Scores on a scale
Standard Error 0.181
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set population (FAS): included all randomized participants; Here 'n' = number of evaluable participants at the specific time point.
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=80 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=82 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Change From Baseline to Week 12 in WOMAC Physical Function Subscale Score
|
-1.74 Scores on a scale
Standard Error 0.180
|
-2.09 Scores on a scale
Standard Error 0.183
|
-1.75 Scores on a scale
Standard Error 0.182
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set population (FAS): included all randomized participants; Here 'n' = number of evaluable participants at the specific time point.
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=80 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=82 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Patient Global Assessment (PGA) Score
|
-0.59 Scores on a scale
Standard Error 0.076
|
-0.75 Scores on a scale
Standard Error 0.078
|
-0.80 Scores on a scale
Standard Error 0.078
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set population (FAS): included all randomized participants; Here 'n' = number of evaluable participants at the specific time point.
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=80 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=82 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Change From Baseline to Week 12 in WOMAC Stiffness Subscale Score
|
-1.70 Scores on a scale
Standard Error 0.214
|
-2.20 Scores on a scale
Standard Error 0.217
|
-1.88 Scores on a scale
Standard Error 0.217
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set population (FAS): included all randomized participants
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=86 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=85 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Percentage of Participants With ≥30% Improvement in WOMAC Pain Subscale Score
|
51.1 Percentage of participants
|
58.1 Percentage of participants
|
47.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Safety Analysis Set (SAF): included all randomized participants who received any study drug
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. Treatment-emergent AEs (TEAEs) are AEs that developed or worsened during the treatment period.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=85 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=84 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study
Non-Serious TEAEs
|
78 Events
|
42 Events
|
55 Events
|
|
Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study
Serious TEAEs
|
0 Events
|
2 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Safety Analysis Set (SAF): included all randomized participants who received any study drug
Adjudicated arthropathy is an umbrella term referring to Rapidly Progressive Osteoarthritis Type 1 (RPOA-1), Rapidly Progressive Osteoarthritis Type 2 (RPOA-2), subchondral insufficiency fractures (SIF) and osteonecrosis (ON) confirmed by an arthropathy adjudication committee.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=85 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=84 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study
Baseline Up to and Including Week 12 Visit
|
1 Events
|
0 Events
|
0 Events
|
|
Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study
After Week 12 Visit, Up to and Including Week 36
|
0 Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Anti-Drug Antibody (ADA) Analysis Set: included all treated participants who received any amount of study drug (active or placebo \[safety analysis set (SAF)\]) and had at least one non-missing anti-REGN5069 antibody result following the first dose of study drug or placebo. ADA analysis set is based on actual treatment received, rather than randomized.
Immunogenicity will be characterized by ADA responses \& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, ≥ 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the REG5069 ADA assay post first dose when baseline results = negative or missing.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg Q4W
n=83 Participants
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg Q4W
n=82 Participants
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study
Negative
|
82 Participants
|
83 Participants
|
78 Participants
|
|
Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study
Pre-Existing Immunoreactivity
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study
Treatment-Boosted Response
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study
Treatment-Emergent Response
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
REGN5069 100 mg IV Q4W
REGN5069 1000 mg IV Q4W
Serious adverse events
| Measure |
Placebo
n=88 participants at risk
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg IV Q4W
n=85 participants at risk
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg IV Q4W
n=84 participants at risk
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
1.1%
1/88 • Number of events 1 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/85 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/84 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/88 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
1.2%
1/85 • Number of events 1 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/84 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/88 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
1.2%
1/85 • Number of events 1 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/84 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.1%
1/88 • Number of events 1 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/85 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/84 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
1/88 • Number of events 1 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/85 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/84 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/88 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
1.2%
1/85 • Number of events 1 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/84 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/88 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
1.2%
1/85 • Number of events 1 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/84 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/88 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
1.2%
1/85 • Number of events 1 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/84 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
Other adverse events
| Measure |
Placebo
n=88 participants at risk
Participants received matching placebo intravenously every 4 weeks (Q4W)
|
REGN5069 100 mg IV Q4W
n=85 participants at risk
Participants received 100 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
REGN5069 1000 mg IV Q4W
n=84 participants at risk
Participants received 1000 milligrams (mg) of REGN5069 intravenously every 4 weeks (Q4W)
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
34.1%
30/88 • Number of events 64 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
22.4%
19/85 • Number of events 36 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
23.8%
20/84 • Number of events 47 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
11/88 • Number of events 14 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
4.7%
4/85 • Number of events 4 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
8.3%
7/84 • Number of events 10 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Infections and infestations
Urinary tract infection
|
10.2%
9/88 • Number of events 14 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
4.7%
4/85 • Number of events 5 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
6.0%
5/84 • Number of events 6 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.2%
9/88 • Number of events 14 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
3.5%
3/85 • Number of events 4 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
9.5%
8/84 • Number of events 8 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
6/88 • Number of events 7 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
10.6%
9/85 • Number of events 17 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
8.3%
7/84 • Number of events 9 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
|
Gastrointestinal disorders
Toothache
|
11.4%
10/88 • Number of events 15 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
5.9%
5/85 • Number of events 7 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
0.00%
0/84 • Adverse events (AE) and Serious Adverse Events (SAE) were collected from the time of informed consent signature and then at each visit until the end of follow-up visit (week 36) for AEs and until end of study visit (week 52) for SAEs. The study was terminated early at 36 weeks.
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER