Trial Outcomes & Findings for Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge (NCT NCT03838731)
NCT ID: NCT03838731
Last Updated: 2021-07-01
Results Overview
Time to EAR was defined as the time to a ≥20% reduction in FEV1 or when the participant voluntarily departed the EEU due to clinically significant allergic and/or asthmatic symptoms.
COMPLETED
PHASE2
56 participants
Day 8
2021-07-01
Participant Flow
A total of 130 participants were screened for study eligibility. Screen failures were mostly attributed to eligibility criteria not being met. The study was conducted at one site in France.
A total of 56 participants were randomized in a 1:1 ratio to receive a single dose of either 600 milligrams (mg) of REGN1908-1909 or matching placebo.
Participant milestones
| Measure |
Placebo
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
29
|
|
Overall Study
COMPLETED
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Withdrawal of consent
|
1
|
0
|
Baseline Characteristics
Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=29 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.2 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
28.4 Years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
29.3 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: Full analysis set: included all randomized participants who received any investigational product and had completed the Day 8 Cat Allergen Challenge.
Time to EAR was defined as the time to a ≥20% reduction in FEV1 or when the participant voluntarily departed the EEU due to clinically significant allergic and/or asthmatic symptoms.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=29 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Time to Early Asthmatic Response (EAR) Upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU) on Day 8
|
51 Minutes
Interval 33.92 to 70.7
|
NA Minutes
Interval 130.87 to
The median time to EAR could not be estimated in the REGN1908-1909 arm at the day 8 visit since a majority of participants were able to tolerate the full 4 hours of cat allergen exposure, the maximum time allowed in the EEU per protocol, without experiencing an EAR (censored at 4 hours)
|
SECONDARY outcome
Timeframe: Days 29, 57 and 85Population: Full analysis set: included all randomized participants who received any investigational product and had completed the Day 8 Cat Allergen Challenge. Here "n" = number of evaluable participants analyzed at each time point
Time to EAR was defined as the time to a ≥20% reduction in FEV1 or when the participant voluntarily departed the EEU due to clinically significant allergic and/or asthmatic symptoms
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=29 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Time to EAR Upon Controlled Cat Allergen Challenge in an EEU on Days 29, 57, and 85
Day 29
|
41 Minutes
Interval 31.38 to 61.13
|
NA Minutes
Interval 131.22 to
Time to EAR, post-baseline, was censored at 4 hours if the participant remained in the EEU for the maximum time and did not experience an EAR. Baseline EEU maximum exposure was 2 hours.
|
|
Time to EAR Upon Controlled Cat Allergen Challenge in an EEU on Days 29, 57, and 85
Day 57
|
56 Minutes
Interval 40.52 to 80.63
|
232 Minutes
Interval 81.05 to
Time to EAR, post-baseline, was censored at 4 hours if the participant remained in the EEU for the maximum time and did not experience an EAR. Baseline EEU maximum exposure was 2 hours.
|
|
Time to EAR Upon Controlled Cat Allergen Challenge in an EEU on Days 29, 57, and 85
Day 85
|
41 Minutes
Interval 31.03 to 60.93
|
NA Minutes
Interval 90.97 to
Time to EAR, post-baseline, was censored at 4 hours if the participant remained in the EEU for the maximum time and did not experience an EAR. Baseline EEU maximum exposure was 2 hours.
|
SECONDARY outcome
Timeframe: Days 8, 29, 57, and 85Population: Full analysis set; Here 'n' = number of evaluable participants analyzed at each time point. For each participant at each controlled cat allergen challenge, AUC was calculated over the time period of 0 to 2 hours, with last observation carried forward used to impute values out to 2 hours if the patients remained in EEU for less than 2 hours. The AUCs were calculated using the trapezoidal rule and were normalized by dividing by the length of time (2 hours).
The AUC was analyzed by mixed-effect model repeated measures (MMRM) with the treatment, time, treatment-by-time interaction, and day of challenge as factors and baseline FEV1 AUC as a continuous covariate.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=29 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Percent Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 8
|
1.59 Percentage of change
Standard Error 2.58
|
15.15 Percentage of change
Standard Error 2.50
|
|
Percent Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 29
|
0.46 Percentage of change
Standard Error 3.60
|
16.67 Percentage of change
Standard Error 3.43
|
|
Percent Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 57
|
1.77 Percentage of change
Standard Error 3.55
|
14.07 Percentage of change
Standard Error 3.43
|
|
Percent Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 85
|
0.20 Percentage of change
Standard Error 3.28
|
12.73 Percentage of change
Standard Error 3.14
|
SECONDARY outcome
Timeframe: Days 8, 29, 57, and 85Population: Full analysis set; Here "n" = number of evaluable participants analyzed at each time point. For each participant at each controlled cat allergen challenge, AUC was calculated over the time period of 0 to 2 hours, with last observation carried forward used to impute values out to 2 hours if the patients remained in EEU for less than 2 hours. The AUCs were calculated using the trapezoidal rule and were normalized by dividing by the length of time (2 hours).
The AUC was analyzed by mixed-effect model repeated measures (MMRM) with the treatment, time, treatment-by-time interaction, and day of challenge as factors and baseline FEV1 AUC as a continuous covariate.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=29 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 8
|
0.01 Liters (L)
Standard Error 0.06
|
0.38 Liters (L)
Standard Error 0.06
|
|
Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 29
|
-0.03 Liters (L)
Standard Error 0.08
|
0.43 Liters (L)
Standard Error 0.08
|
|
Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 57
|
0.00 Liters (L)
Standard Error 0.08
|
0.34 Liters (L)
Standard Error 0.07
|
|
Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 85
|
-0.05 Liters (L)
Standard Error 0.08
|
0.32 Liters (L)
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Days 8, 29, 57 and 85Population: Full analysis set; Here 'n' = number of evaluable participants analyzed at each time point. For each participant at each controlled cat allergen challenge, AUC was calculated over the time period of 0 to 2 hours, with last observation carried forward used to impute values out to 2 hours if participants remained in EEU for less than 2 hours. AUCs were calculated using trapezoidal rule and were normalized by dividing by the length of time (2 hours).
Individual nasal symptoms, including rhinorrhea, nasal congestion, nasal itching, and sneezing were evaluated on a 4-point Likert scale (0, none; 1, mild; 2, moderate; and 3, severe) and combined to give the Total Nasal Symptom Score (TNSS) with a maximum score of 12. Scale range is 0-12. The higher the score, the more severe the symptoms.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=29 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Change From Baseline in the Normalized AUC of Patient-Assessed Nasal Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 8
|
-0.71 Scores on a scale
Standard Error 0.38
|
-0.49 Scores on a scale
Standard Error 0.38
|
|
Change From Baseline in the Normalized AUC of Patient-Assessed Nasal Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 29
|
-0.70 Scores on a scale
Standard Error 0.37
|
-1.39 Scores on a scale
Standard Error 0.34
|
|
Change From Baseline in the Normalized AUC of Patient-Assessed Nasal Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 57
|
-0.93 Scores on a scale
Standard Error 0.43
|
-0.83 Scores on a scale
Standard Error 0.43
|
|
Change From Baseline in the Normalized AUC of Patient-Assessed Nasal Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 85
|
-0.49 Scores on a scale
Standard Error 0.43
|
-1.37 Scores on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Days 8, 29, 57 and 85Population: Full analysis set; Here 'n' = number of evaluable participants analyzed at each time point. For each participant at each controlled cat allergen challenge, AUC was calculated over the time period of 0 to 2 hours, with last observation carried forward used to impute values out to 2 hours if participants remained in EEU for less than 2 hours. AUCs were calculated using trapezoidal rule and were normalized by dividing by the length of time (2 hours).
Individual ocular symptoms for itching/burning, redness, swelling/puffiness, and tearing/watery eyes were evaluated on a 4-point Likert scale (0, none; 1, mild; 2, moderate; and 3, severe) and combined to give the TOSS, with a maximum score of 12. Score range is 0-12. The higher the score, the more severe the symptoms.
Outcome measures
| Measure |
Placebo
n=25 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=28 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Change From Baseline in the Normalized AUC in Patient-Assessed Ocular Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 8
|
-0.37 Scores on a scale
Standard Error 0.17
|
-0.23 Scores on a scale
Standard Error 0.17
|
|
Change From Baseline in the Normalized AUC in Patient-Assessed Ocular Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 29
|
-0.43 Scores on a scale
Standard Error 0.15
|
-0.43 Scores on a scale
Standard Error 0.14
|
|
Change From Baseline in the Normalized AUC in Patient-Assessed Ocular Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 57
|
-0.40 Scores on a scale
Standard Error 0.15
|
-0.34 Scores on a scale
Standard Error 0.15
|
|
Change From Baseline in the Normalized AUC in Patient-Assessed Ocular Symptoms Induced by a Controlled Cat Allergen Challenge Over the Exposure Interval to the Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Day 85
|
-0.36 Scores on a scale
Standard Error 0.11
|
-0.51 Scores on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Days 8, 29, 57 and 85Population: Full analysis set: included all randomized participants who received any investigational product and had completed the Day 8 Cat Allergen Challenge; Here "n" = number of evaluable participants analyzed at each time point
Cat Allergen Exposure Tolerated in ng = Minute Ventilation (L/min) x Allergen Concentration (ng/m3) x Time in EEU (minutes), where 1 L/min = 0.001 m3/min. The change in cat allergen quantity (tolerated exposure) from the baseline Cat Allergen Challenge, will be analyzed using a similar MMRM model with treatment, visit and treatment by-visit interaction as factors and the cat allergen quantity tolerated in the baseline Controlled Cat Allergen Challenge as a covariate.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=29 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Mean Change From Baseline in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
Day 8
|
19.55 Nanograms (ng)
Standard Error 8.93
|
59.05 Nanograms (ng)
Standard Error 8.70
|
|
Mean Change From Baseline in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
Day 29
|
14.14 Nanograms (ng)
Standard Error 8.67
|
68.21 Nanograms (ng)
Standard Error 8.21
|
|
Mean Change From Baseline in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
Day 57
|
21.94 Nanograms (ng)
Standard Error 10.23
|
55.38 Nanograms (ng)
Standard Error 9.93
|
|
Mean Change From Baseline in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
Day 85
|
12.93 Nanograms (ng)
Standard Error 9.29
|
54.03 Nanograms (ng)
Standard Error 8.94
|
SECONDARY outcome
Timeframe: Days 8, 29, 57 and 85Population: Full analysis set: included all randomized participants who received any investigational product and had completed the Day 8 Cat Allergen Challenge; Here "n" = number of evaluable participants analyzed at each time point
Cat Allergen Exposure Tolerated in ng = Minute Ventilation (L/min) x Allergen Concentration (ng/m3) x Time in EEU (minutes), where 1 L/min = 0.001 m3/min. The change in cat allergen quantity (tolerated exposure) from the baseline Cat Allergen Challenge, will be analyzed using a similar MMRM model with treatment, visit and treatment by-visit interaction as factors and the cat allergen quantity tolerated in the baseline Controlled Cat Allergen Challenge as a covariate.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=29 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Percent Change in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
Day 8
|
119.86 Percentage of change
Standard Error 73.22
|
325.29 Percentage of change
Standard Error 70.79
|
|
Percent Change in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
Day 29
|
93.62 Percentage of change
Standard Error 71.48
|
338.22 Percentage of change
Standard Error 68.26
|
|
Percent Change in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
Day 57
|
118.08 Percentage of change
Standard Error 69.58
|
301.11 Percentage of change
Standard Error 67.11
|
|
Percent Change in Cat Allergen Quantity as Experienced by Participants During Exposure on Days 8, 29, 57, and 85
Day 85
|
76.75 Percentage of change
Standard Error 82.08
|
317.76 Percentage of change
Standard Error 78.84
|
SECONDARY outcome
Timeframe: Baseline to 16 weeksPopulation: Safety Analysis Set (SAF): included all participants who received any investigational product and were analyzed as treated.
Adverse events and serious adverse events were collected from the time of informed consent signature and then at each visit until the end of the study with the exception of symptoms that occurred in response to the EEU within 24 hours following the EEU.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received a single dose of matching placebo
|
REGN1908-1909 600 mg
n=29 Participants
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study
Non-serious TEAEs
|
66 Events
|
76 Events
|
|
Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study
Serious TEAEs
|
0 Events
|
0 Events
|
Adverse Events
Placebo
REGN1908-1909 600mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Participants received a single dose of matching placebo
|
REGN1908-1909 600mg
n=29 participants at risk
Participants received a single 600 mg dose of REGN1908-1909
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
59.3%
16/27 • Number of events 35 • Baseline (day 1) to the end of study (week 16)
|
37.9%
11/29 • Number of events 19 • Baseline (day 1) to the end of study (week 16)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
11.1%
3/27 • Number of events 3 • Baseline (day 1) to the end of study (week 16)
|
3.4%
1/29 • Number of events 1 • Baseline (day 1) to the end of study (week 16)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.4%
2/27 • Number of events 2 • Baseline (day 1) to the end of study (week 16)
|
17.2%
5/29 • Number of events 5 • Baseline (day 1) to the end of study (week 16)
|
|
General disorders
Influenza like illness
|
14.8%
4/27 • Number of events 4 • Baseline (day 1) to the end of study (week 16)
|
10.3%
3/29 • Number of events 3 • Baseline (day 1) to the end of study (week 16)
|
|
General disorders
Injection site pain
|
3.7%
1/27 • Number of events 1 • Baseline (day 1) to the end of study (week 16)
|
6.9%
2/29 • Number of events 2 • Baseline (day 1) to the end of study (week 16)
|
|
Infections and infestations
Gastroenteritis
|
7.4%
2/27 • Number of events 2 • Baseline (day 1) to the end of study (week 16)
|
3.4%
1/29 • Number of events 1 • Baseline (day 1) to the end of study (week 16)
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
2/27 • Number of events 2 • Baseline (day 1) to the end of study (week 16)
|
6.9%
2/29 • Number of events 2 • Baseline (day 1) to the end of study (week 16)
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Number of events 2 • Baseline (day 1) to the end of study (week 16)
|
17.2%
5/29 • Number of events 5 • Baseline (day 1) to the end of study (week 16)
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/27 • Baseline (day 1) to the end of study (week 16)
|
10.3%
3/29 • Number of events 3 • Baseline (day 1) to the end of study (week 16)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • Baseline (day 1) to the end of study (week 16)
|
6.9%
2/29 • Number of events 2 • Baseline (day 1) to the end of study (week 16)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/27 • Baseline (day 1) to the end of study (week 16)
|
6.9%
2/29 • Number of events 2 • Baseline (day 1) to the end of study (week 16)
|
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