Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04021862 | A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis | PHASE2 | COMPLETED | 87 | — | — | Oct 16, 2019 | Nov 19, 2020 | Feb 4, 2025 | 17 | United States |
| NCT03496974 | A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis | PHASE2 | COMPLETED | 38 | — | — | May 21, 2018 | Dec 11, 2018 | Mar 12, 2021 | 1 | United States |
Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response was defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. This outcome measure was planned to be analyzed for specified arms only.
Safety and tolerability endpoints were evaluated by monitoring all the adverse events from clinical and laboratory reporting, vital signs, physical examinations, ECG and urinalysis. All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. AEs are coded using medical dictionary - MedDRA Version 21.0 and the severity was assigned using CTCAE version 4.03.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1 (bermekimab every week) | EXPERIMENTAL | Loading Dose: 400 mg subcutaneous (SC) injection of bermekimab and a SC injection of matching placebo at week 0 (Baseline). Treatment Dose: 400 mg subcutaneous injection of bermekimab administered weekly (qw) from week 1 through Week 31. |
| Treatment Arm 2 (bermekimab every other week) | EXPERIMENTAL | Loading Dose: 800 mg SC injection of bermekimab at week 0 (Baseline). Treatment Dose: 400 mg SC injection of bermekimab administered every other week (q2w) alternating with matching placebo q2w through Week 31. |
| Placebo | PLACEBO_COMPARATOR | Loading Dose: Placebo matching to bermekimab (4 milliliters \[mL\]) SC injection at Week 0, (Baseline). Treatment Dose: SC injection of matching placebo administered once weekly (qw) from week 1 to week 15 during placebo-controlled period. After completion of placebo-controlled period, participants will cross-over and receive bermekimab 400 mg SC injection qw at Week 16 through Week 31. |
| Group A: 200 mg cohort | EXPERIMENTAL | The dose of bermekimab for Group A is 200 mg (2ml of the 100 mg/ml formulation) |
| Group B: 400 mg cohort | EXPERIMENTAL | The dose of bermekimab for Group B is 400 mg (2ml of the 200 mg/ml formulation) administered weekly by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Bermekimab Monoclonal Antibody | DRUG | Bermekimab 400 mg or 800 mg will be administered subcutaneously. |
| Placebo | DRUG | Placebo will be administered subcutaneously. |
| Bermekimab Monoclonal Antibody 200 mg | DRUG | 200 mg subcutaneous injection |
| Bermekimab Monoclonal Antibody 400 mg | DRUG | 400 mg subcutaneous injection |
Inclusion Criteria: * Male or female, at least 18 years * Willing and able to attend all clinic visits and comply with study-related procedures * Participant can understand and complete study-related questionnaires * Written informed consent provided by the participant * Chronic atopic dermatitis p...