NCT03496974

A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis

A Phase II, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 study of Bermekimab (MABp1) in patients with atopic dermatitis.

Detailed description

A Phase 2, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients with Moderate to Severe Atopic Dermatitis. The study is multi center and will consist of two dose levels: Group A (n=9): patients will receive a total of 4 x 200mg subcutaneous injections of bermekimab. Dosing will occur weekly from visit 1 to visit 4, inclusive. Group B (n=20): patients will receive a total of 8 x 400 mg subcutaneous injections of bermedimkb. Dosing will occur weekly from visit 1 to visit 8, inclusive.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Bermekimab Monoclonal Antibody 200 mg	200 mg subcutaneous injection
DRUG	Bermekimab Monoclonal Antibody 400 mg	400 mg subcutaneous injection

Timeline

• Start date: 2018-05-21
• Primary completion: 2018-12-04
• Completion: 2018-12-11
• First posted: 2018-04-12
• Last updated: 2021-03-12
• Results posted: 2019-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study