NCT03512275

A Study of Bermekimab in Patients With Hidradenitis Suppurativa

A Phase II, Open Label Study of Bermekimab in Patients With Moderate to Severe Hidradenitis Suppurativa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 study of bermekimab in patients with moderate to severe Hidradenitis Suppurativa.

Detailed description

Phase 2, open label study of bermekimab in patients with moderate to severe Hidradenitis Suppurativa. The study is multicenter and will consist of two patient groups, each of which will receive a total of 13 X 400mg weekly subcutaneous injections of bermekimab: Group A (n=10) patients who have failed anti-TNF therapy, and Group B (n=10) patients who have had no prior treatment with biological agents that block TNF. Patients will be followed for 13 weeks to allow for assessment of safety and preliminary efficacy. Additionally, patients who had received the 200 mg weekly subcutaneous injections of bermekimab under the previous version of this protocol are eligible to begin receiving the 400 mg dose starting with his/her next scheduled visit, and for the remainder of his/her treatment plan. XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Bermekimab Monoclonal Antibody 400 mg	subcutaneous injection

Timeline

• Start date: 2018-06-20
• Primary completion: 2019-01-14
• Completion: 2019-01-14
• First posted: 2018-04-30
• Last updated: 2022-03-14
• Results posted: 2022-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study