Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis (NCT NCT03633396)
NCT ID: NCT03633396
Last Updated: 2025-09-15
Results Overview
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease, and a negative change from Baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2025-09-15
Participant Flow
Participants were enrolled in this trial at 36 sites located within North America and Europe.
Participants were randomized equally to one of two treatment groups. Randomization was stratified based on the participant's history of plaque psoriasis, to ensure that the number of participants enrolled with plaque psoriasis did not exceed 50%.
Participant milestones
| Measure |
Placebo
Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
|
Imsidolimab
Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
|
Imsidolimab
Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Coronavirus Disease 2019 (COVID-19) Restrictions
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
|
Imsidolimab
n=30 Participants
Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 10.59 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 12.10 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Palmoplantar Pustulosis Psoriasis Area Severity Index Score
|
19.47 score on a scale
STANDARD_DEVIATION 11.633 • n=5 Participants
|
16.18 score on a scale
STANDARD_DEVIATION 8.045 • n=7 Participants
|
17.80 score on a scale
STANDARD_DEVIATION 10.022 • n=5 Participants
|
|
History of Plaque Psoriasis
Yes
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
History of Plaque Psoriasis
No
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Intent-to-treat analysis set with available data
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease, and a negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
|
Imsidolimab
n=24 Participants
Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
|
|---|---|---|
|
Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)
|
-6.0 score on a scale
Standard Error 1.48
|
-6.1 score on a scale
Standard Error 1.46
|
PRIMARY outcome
Timeframe: From first dose of any study drug to Week 24Population: Safety Analysis Set (all randomized participants who received at least 1 dose of imsidolimab or placebo).
Clinical safety was evaluated by reporting incidence of adverse events up to week 24. TEAEs are defined as new events that occured during or after first dose of study drug or any event that worsens after first dose of study drug. A serious AE (SAE) is defined as any untoward medical occurrence that resulted in death, was life-threatening, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or an important medical event that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Severity was assessed by the Investigator as mild (easily tolerated, causing minimal discomfort and not interfering with everyday activities), moderate (causes sufficient discomfort and interferes with normal everyday activities) or severe (prevents normal everyday activities). The Investigator assessed the relationship between study treatment and each AE based on clinical judgement.
Outcome measures
| Measure |
Placebo
n=29 Participants
Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
|
Imsidolimab
n=30 Participants
Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE leading to discontinuation of study treatment
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any treatment-emergent adverse event (TEAE)
|
20 Participants
|
21 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE related to study drug
|
3 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Severe TEAE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Serious TEAE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE of special interest
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE leading to study discontinuation
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE leading to death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE related to injection site reaction
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Disease related TEAE
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Intent-to-treat analysis set with available data
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
|
Imsidolimab
n=24 Participants
Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
|
|---|---|---|
|
Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)
|
50.0 percentage of participants
Interval 29.12 to 70.88
|
45.8 percentage of participants
Interval 25.55 to 67.18
|
SECONDARY outcome
Timeframe: Week 16Population: Intent-to-treat analysis set with available data
The Investigator rated the severity of participants' disease on the following 5-point scale: * 0: Clear - No signs of palmoplantar pustulosis; no scaling or crusts or pustules remain; * 1: Almost clear - Slight scaling and/or erythema and/or slight crusts; very few (yellow) and/or old (brown) pustules; * 2: Mild - Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent; * 3: Moderate - Prominent scaling and/or erythema and/or crusting; prominent new (yellow) and/or old (brown) pustules covering most of the area involved; * 4: Severe - Severe scaling and/or erythema and/or crusting; numerous new (yellow) and/or old (brown) pustules with / without major confluence, covering the entire area of at least 2 palmoplantar sites.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
|
Imsidolimab
n=24 Participants
Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16
|
12.5 percentage of participants
Interval 2.66 to 32.36
|
20.8 percentage of participants
Interval 7.13 to 42.15
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Imsidolimab
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=29 participants at risk
Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
|
Imsidolimab
n=30 participants at risk
Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion early
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
Other adverse events
| Measure |
Placebo
n=29 participants at risk
Participants received placebo administered by subcutaneous injection on Day 1 followed by monthly doses on Days 29, 57, and 85.
|
Imsidolimab
n=30 participants at risk
Participants received 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
13.8%
4/29 • From first dose of any study drug to Week 24
|
13.3%
4/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
6.7%
2/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
COVID-19
|
6.9%
2/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Otitis externa
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Rhinitis
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Bacterial pyelonephritis
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Bronchitis viral
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Conjunctivitis
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Folliculitis
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Gastrointestinal infection
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Impetigo
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
6.7%
2/30 • From first dose of any study drug to Week 24
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Gastrointestinal disorders
Toothache
|
13.8%
4/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Investigations
Blood pressure increased
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Investigations
Blood triglycerides increased
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • From first dose of any study drug to Week 24
|
6.7%
2/30 • From first dose of any study drug to Week 24
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Nervous system disorders
Anosmia
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Nervous system disorders
Intercostal neuralgia
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Nervous system disorders
Neuralgia
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Nervous system disorders
Sciatica
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
6.7%
2/30 • From first dose of any study drug to Week 24
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Skin and subcutaneous tissue disorders
Palmoplantar pustulosis
|
17.2%
5/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
General disorders
Pyrexia
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
6.7%
2/30 • From first dose of any study drug to Week 24
|
|
General disorders
Fatigue
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
General disorders
Peripheral swelling
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
6.7%
2/30 • From first dose of any study drug to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
3.3%
1/30 • From first dose of any study drug to Week 24
|
|
Eye disorders
Blepharospasm
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
3.4%
1/29 • From first dose of any study drug to Week 24
|
0.00%
0/30 • From first dose of any study drug to Week 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may not publish trial results until after the first multi-center publication unless such publication is not published within a period that is at least 18 months but less than or equal to 24 months after trial completion. In addition, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER