Trial Outcomes & Findings for Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome (NCT NCT03790865)
NCT ID: NCT03790865
Last Updated: 2021-02-17
Results Overview
Change from baseline to the end of the 3-month Core Period for HQ-CT total score. The HQ-CT score range is 0 to 36 where the higher score represents more severe abnormal food related behaviors.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
158 participants
Primary outcome timeframe
Baseline to month 3
Results posted on
2021-02-17
Participant Flow
Original protocol: for Phase 2b, a total of 50 patients per group will need to be randomized. Amendment v1.2: for Phase 2b, a total of approximately 50 patients per group (8 to 65 years of age) will need to be randomized. In addition to this cohort of 150 patients, a separate cohort of patients 4 to 7 years of age will also be randomized.
Screening Period was up to 4 weeks. After signing informed consent, patients with Prader-Willi Syndrome entered the Screening Period to assess preliminary eligibility for the study based on the inclusion and exclusion criteria. In addition, pertinent information was collected such as past medical history, demographic data, and prior and current medications
Participant milestones
| Measure |
Low-Dose Livoletide
Daily subcutaneous injection of \~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
High-Dose Livoletide
Daily subcutaneous injection of \~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
Placebo
Daily subcutaneous injection of 0.9% sodium chloride for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.
Placebo: Daily subcutaneous injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
54
|
|
Overall Study
COMPLETED
|
52
|
50
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
Baseline characteristics by cohort
| Measure |
Low-Dose Livoletide
n=52 Participants
Daily subcutaneous injection of \~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
High-Dose Livoletide
n=52 Participants
Daily subcutaneous injection of \~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
Placebo
n=54 Participants
Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.
Placebo: Daily subcutaneous injection
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
20.7 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
19.7 years
STANDARD_DEVIATION 8.27 • n=7 Participants
|
19.4 years
STANDARD_DEVIATION 8.03 • n=5 Participants
|
19.9 years
STANDARD_DEVIATION 8.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Baseline HQ-CT
|
20.4 units on a scale
STANDARD_DEVIATION 6.37 • n=5 Participants
|
19.5 units on a scale
STANDARD_DEVIATION 6.34 • n=7 Participants
|
20.5 units on a scale
STANDARD_DEVIATION 5.87 • n=5 Participants
|
20.2 units on a scale
STANDARD_DEVIATION 6.15 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to month 3Population: The Full Analysis Set (FAS) included all randomized patients. Efficacy analyses for the Phase 2b Core Period were performed on the FAS.
Change from baseline to the end of the 3-month Core Period for HQ-CT total score. The HQ-CT score range is 0 to 36 where the higher score represents more severe abnormal food related behaviors.
Outcome measures
| Measure |
Low-Dose Livoletide
n=52 Participants
Daily subcutaneous injection of \~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
High-Dose Livoletide
n=52 Participants
Daily subcutaneous injection of \~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
Placebo
n=54 Participants
Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.
Placebo: Daily subcutaneous injection
|
|---|---|---|---|
|
Change in Hyperphagia and Food-related Behaviors (Hyperphagia Questionnaire for Clinical Trials; HQ-CT)
|
-5.1 score on a scale
Standard Error 7.76
|
-3.6 score on a scale
Standard Error 6.08
|
-3.3 score on a scale
Standard Error 5.77
|
SECONDARY outcome
Timeframe: Baseline to month 3Population: The Full Analysis Set (FAS) included all randomized patients. Efficacy analyses for the Phase 2b Core Period were performed on the FAS. For this endpoint, only patients considered overweight/obese at baseline were included in the analysis. Overweight/obese patients were defined as follows: * patients ≥18 years of age: BMI ≥27 kg/m2 * patients 4-17 years of age: BMI ≥90th percentile for the same age and sex
Total body fat mass was assessed using dual energy X-ray absorptiometry (DXA) scan. DXAs were conducted at each local facility using standardized procedures and settings. Overweight/obese patients were defined as follows: * patients ≥18 years of age: BMI ≥27 kg/m2 * patients 4-17 years of age: BMI ≥90th percentile for the same age and sex
Outcome measures
| Measure |
Low-Dose Livoletide
n=40 Participants
Daily subcutaneous injection of \~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
High-Dose Livoletide
n=39 Participants
Daily subcutaneous injection of \~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
Placebo
n=40 Participants
Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.
Placebo: Daily subcutaneous injection
|
|---|---|---|---|
|
Percentage Change From Baseline to Month 3 in Total Body Fat Mass in Patients Eight to 65 Years of Age Defined as Overweight/Obese
|
0.33 percent change
Standard Deviation 3.806
|
3.48 percent change
Standard Deviation 4.429
|
-0.36 percent change
Standard Deviation 4.302
|
SECONDARY outcome
Timeframe: Baseline to month 3Population: The Full Analysis Set (FAS) included all randomized patients. Efficacy analyses for the Phase 2b Core Period were performed on the FAS. For this endpoint, only patients considered overweight/obese at baseline were included in the analysis. Overweight/obese patients were defined as follows: * patients ≥18 years of age: BMI ≥27 kg/m2 * patients 4-17 years of age: BMI ≥90th percentile for the same age and sex
The waist circumference was measured in fasting condition at the superior border of iliac crest, according to recommendations from the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey, Revised 2007. Overweight/obese patients were defined as follows: * patients ≥18 years of age: BMI ≥27 kg/m2 * patients 4-17 years of age: BMI ≥90th percentile for the same age and sex
Outcome measures
| Measure |
Low-Dose Livoletide
n=40 Participants
Daily subcutaneous injection of \~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
High-Dose Livoletide
n=39 Participants
Daily subcutaneous injection of \~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
Placebo
n=40 Participants
Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.
Placebo: Daily subcutaneous injection
|
|---|---|---|---|
|
Change From Baseline to Month 3 in Waist Circumference in Patients Eight to 65 Years of Age Defined as Overweight/Obese
|
0.92 cm
Standard Deviation 5.703
|
0.11 cm
Standard Deviation 4.969
|
-0.45 cm
Standard Deviation 3.674
|
SECONDARY outcome
Timeframe: Baseline to month 3Population: The Full Analysis Set (FAS) included all randomized patients. Efficacy analyses for the Phase 2b Core Period were performed on the FAS. For this endpoint, only patients considered overweight/obese at baseline were included in the analysis. Overweight/obese patients were defined as follows: * patients ≥18 years of age: BMI ≥27 kg/m2 * patients 4-17 years of age: BMI ≥90th percentile for the same age and sex
Patients were weighed in fasting condition, clothed (underwear, light gown or light clothing), without footwear or heavy jewelry, using a calibrated scale. The same scale should be used throughout the study if possible. The conditions under which patients are weighed should be kept consistent if possible. Overweight/obese patients were defined as follows: * patients ≥18 years of age: BMI ≥27 kg/m2 * patients 4-17 years of age: BMI ≥90th percentile for the same age and sex
Outcome measures
| Measure |
Low-Dose Livoletide
n=40 Participants
Daily subcutaneous injection of \~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
High-Dose Livoletide
n=39 Participants
Daily subcutaneous injection of \~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
Placebo
n=40 Participants
Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.
Placebo: Daily subcutaneous injection
|
|---|---|---|---|
|
Percentage Change From Baseline to Month 3 in Body Weight in Patients Eight to 65 Years of Age Defined as Overweight/Obese
|
1.39 percent change
Standard Deviation 3.313
|
1.79 percent change
Standard Deviation 2.079
|
1.06 percent change
Standard Deviation 2.589
|
Adverse Events
Low-Dose Livoletide
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
High-Dose Livoletide
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-Dose Livoletide
n=52 participants at risk
Daily subcutaneous injection of \~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
High-Dose Livoletide
n=52 participants at risk
Daily subcutaneous injection of \~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
Placebo
n=54 participants at risk
Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.
Placebo: Daily subcutaneous injection
|
|---|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Psychiatric disorders
Impulse control disorder
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/54 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Nervous system disorders
Syncope
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
Other adverse events
| Measure |
Low-Dose Livoletide
n=52 participants at risk
Daily subcutaneous injection of \~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
High-Dose Livoletide
n=52 participants at risk
Daily subcutaneous injection of \~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide: Daily subcutaneous injection
|
Placebo
n=54 participants at risk
Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.
Placebo: Daily subcutaneous injection
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
8/52 • Number of events 10 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
7.7%
4/52 • Number of events 4 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
9.3%
5/54 • Number of events 5 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.7%
2/54 • Number of events 3 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/54 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.7%
2/54 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
General disorders
Injection site pain
|
15.4%
8/52 • Number of events 11 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
11.5%
6/52 • Number of events 6 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.7%
2/54 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
General disorders
Injection site bruising
|
5.8%
3/52 • Number of events 3 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
9.6%
5/52 • Number of events 5 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
5.6%
3/54 • Number of events 3 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
General disorders
Injection site erythma
|
9.6%
5/52 • Number of events 5 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
General disorders
Pyrexia
|
7.7%
4/52 • Number of events 4 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/54 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
General disorders
Fatigue
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/54 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
General disorders
Injection site hematoma
|
5.8%
3/52 • Number of events 6 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
General disorders
Injection site mass
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/54 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
11.1%
6/54 • Number of events 6 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Infections and infestations
Influenza
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
7.4%
4/54 • Number of events 4 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Infections and infestations
Gastroenteritis
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/54 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Infections and infestations
Upper respiration infection
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
1.9%
1/54 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Infections and infestations
Ear infection
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Infections and infestations
Paronychia
|
3.8%
2/52 • Number of events 3 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Infections and infestations
Sinusitis
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.7%
2/54 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.7%
2/54 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Investigations
Blood pressure systolic increased
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/52 • Number of events 1 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.7%
2/54 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.7%
2/54 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Nervous system disorders
Headache
|
5.8%
3/52 • Number of events 6 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
5.6%
3/54 • Number of events 3 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Psychiatric disorders
Dermatillomania
|
0.00%
0/52 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
4/52 • Number of events 4 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
3.8%
2/52 • Number of events 2 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
0.00%
0/54 • The analysis of treatment-emergent adverse events (TEAEs) was done starting first dose of study drug and through 30 days after the end of the treatment period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place