Trial Outcomes & Findings for A Study of Bermekimab in Patients With Hidradenitis Suppurativa (NCT NCT03512275)
NCT ID: NCT03512275
Last Updated: 2022-03-14
Results Overview
An adverse event is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical or biological agent under study.
COMPLETED
PHASE2
42 participants
Up to Visit 14 (up to Day 93)
2022-03-14
Participant Flow
Participant milestones
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
18
|
|
Overall Study
COMPLETED
|
22
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
A Study of Bermekimab in Patients With Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 13.14 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 12.02 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 12.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 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
|
|
Region of Enrollment
UNITED STATES
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Visit 14 (up to Day 93)Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated.
An adverse event is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical or biological agent under study.
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
21 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated.
Percentage of participants achieving HiSCR at Week 12 was reported. For this score participants were defined as achievers or non-achievers. The positive HiSCR score was defined as a greater than or equal to (\>=) 50% reduction in inflammatory lesion AN count (sum of abscesses and inflammatory nodules), and no increase in abscesses or draining fistulas in hidradenitis suppurativa compared with the lesions counted on visit 1 (baseline).
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
|
62.5 Percentage of Participants
|
61.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Predose at Days 14 (Visit 3), 28 (Visit 5), 56 (Visit 9), 84 (Visit 13)Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. Here, 'N' (number of participants analyzed) is defined as participants evaluable for this outcome measure.
An enzyme-linked immunosorbent assay (ELISA) was developed to specifically measure bermekimab levels in human plasma. The blood samples were collected at each pharmacokinetic (PK) collection time point for PK analysis.
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=23 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=16 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Plasma Concentration of Bermekimab
Visit 3
|
32.7 micrograms per milliliter (mcg/mL)
Standard Deviation 18.3
|
36.7 micrograms per milliliter (mcg/mL)
Standard Deviation 22.7
|
|
Plasma Concentration of Bermekimab
Visit 5
|
37.4 micrograms per milliliter (mcg/mL)
Standard Deviation 20.7
|
42.2 micrograms per milliliter (mcg/mL)
Standard Deviation 25.0
|
|
Plasma Concentration of Bermekimab
Visit 9
|
36.3 micrograms per milliliter (mcg/mL)
Standard Deviation 20.9
|
48.0 micrograms per milliliter (mcg/mL)
Standard Deviation 31.7
|
|
Plasma Concentration of Bermekimab
Visit 13
|
42.1 micrograms per milliliter (mcg/mL)
Standard Deviation 21.1
|
55.8 micrograms per milliliter (mcg/mL)
Standard Deviation 43.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated.
Change from baseline in VAS score for disease was reported. The VAS is a validated, subjective measure for participants disease impression. Disease impression scores were recorded using a similar scale, with 0 representing "not at all severe" and 10 representing "extremely severe".
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease
|
3.11 Units on scale
Standard Error 0.61
|
3.71 Units on scale
Standard Error 0.75
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated.
Change from baseline in VAS score for pain was reported. The VAS is a validated, subjective measure for acute and chronic pain. Pain scores were recorded by marking a number on a scale from 0 to 10, 0 representing "no pain" and 10 representing "extremely painful".
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Change From Baseline to Week 12 in VAS Score for Pain
|
4.07 Units on scale
Standard Error 0.64
|
5.01 Units on scale
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated.
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of disease symptoms and treatment on Quality of life (QOL). The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL.
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score
|
7.03 Units on scale
Standard Error 1.51
|
11.52 Units on scale
Standard Error 1.85
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated.
PGA is a physician's assessment of the severity of disease based on a 6-point scale (Clear \[0\], minimal \[1\], mild \[2\], moderate \[3\], severe \[4\], more severe \[5\]) ranging from 0-5. Higher score indicated more severity of disease.
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Change From Baseline to Week 12 in Physician's Global Assessment (PGA) Score
|
0.81 Units on scale
Standard Error 0.24
|
1.97 Units on scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated.
The DAS is the sum of scores of all affected areas of each participant. Each area was evaluated by the following formula: (the sum of the two largest diameters in each affected area in millimeter \[mm\]) \* (Total number of lesions in the anatomic area multiplied by the degree of inflammation of each lesion on a scale of 0 to 3). A minimum score of 0 and there is no maximum score range. Higher scores indicate more disease activity.
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) at Week 12
|
35.56 Units on scale
Standard Error 14.96
|
63.84 Units on scale
Standard Error 18.35
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. Data was not collected and analyzed for this outcome measure due to change in planned analysis.
mSS is used to quantify severity of HS. Points are awarded for 12 body areas (left-right axillae, left - right sub/inframammary areas, intermammary area, left - right buttocks, left-right inguinocrural folds, perianal area, perineal area and other): points were awarded for nodules (2 points each);abscesses (4points);fistulas (4points);scars (1point); other findings (1 point); and longest distance between two lesions (no active lesion or only 1 lesion equal to \[=\]0 points, less than \[\<\]5cm=2points, 5-10cm=4points, greater than \[\>\]10cm 6points) and if lesions are separated by normal skin (yes-0 points; no-6points). Total mSS is sum of the 12 regional scores. Change from baseline in mSS was not reported as the electronic data capture (EDC) system erroneously requested data for this endpoint to be input in centimeters versus millimeters and conversion was not possible because it was given in ranges. Therefore, there was not enough valid data to sufficiently perform this endpoint analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated.
Change from baseline to Week 12 in inflammatory lesion (abscesses and inflammatory nodules) count was reported. The sum of abscesses and inflammatory nodules was measured for each participant to assess change in inflammatory lesion counts.
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Change From Baseline to Week 12 in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count
|
6.44 Count of lesions
Standard Error 1.03
|
3.97 Count of lesions
Standard Error 1.29
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated.
The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a patient's emotional state. The HADS consisted of 14 items, 7 each for anxiety and depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores were recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Outcome measures
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 Participants
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 Participants
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Change From Baseline to Week 12 in Hospital Anxiety Depression Scale (HADS)
HADS Anxiety Score
|
3.11 units on a scale
Standard Error 0.88
|
1.33 units on a scale
Standard Error 1.08
|
|
Change From Baseline to Week 12 in Hospital Anxiety Depression Scale (HADS)
HADS Depression Score
|
1.39 units on a scale
Standard Error 0.57
|
0.54 units on a scale
Standard Error 0.70
|
Adverse Events
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
Group B: Bermekimab 400 mg (Anti-TNF Naive)
Serious adverse events
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 participants at risk
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 participants at risk
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
0.00%
0/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
4.2%
1/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
0.00%
0/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
Other adverse events
| Measure |
Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed)
n=24 participants at risk
Participants who did not respond to anti-TNF therapy, received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
Group B: Bermekimab 400 mg (Anti-TNF Naive)
n=18 participants at risk
Participants who did not receive prior treatment with biological agents that block TNF received bermekimab subcutaneously at a dose of 400 mg weekly (13 doses). Participants were followed for 13 weeks to allow for assessment of safety and preliminary efficacy.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
11.1%
2/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
General disorders
Fatigue
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
General disorders
Injection Site Erythema
|
8.3%
2/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
0.00%
0/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
General disorders
Injection Site Reaction
|
8.3%
2/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
11.1%
2/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Infections and infestations
Urinary Tract Infection
|
8.3%
2/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
0.00%
0/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Reproductive system and breast disorders
Penile Oedema
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
5.6%
1/18 • Up to Visit 14 (up to Day 93)
The safety analysis set (SAF) consists of all participants that receive at least one dose of study medication and will be analyzed as treated.
|
Additional Information
Director Clinical Research Dermatology
Janssen Research & Development, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study will be published and/or presented at scientific meetings in a timely manner. The publication policy is described in the contract between the Sponsor and Investigator.
- Publication restrictions are in place
Restriction type: OTHER