An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab

• Status: Withdrawn
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 0 Study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rockefeller University
• Treatments: Antibodies, Monoclonal; Brodalumab

Criteria

Inclusion Criteria:

• Confirmed Diagnosis of Hidradenitis Suppurativa by the PI

• Age 18 or older

• Moderate to Severe Hidradenitis Suppurativa as determined by the PI

• Previously enrolled in JFR-0989

Exclusion Criteria:

• Inflammatory Bowel Disease

• HIV Positive

• Active Hepatitis B or C Infection

• Pregnant or Breastfeeding

• no concurrent use of any systemic antibiotics/retinoids/imunosuppressants (require washout period of >5 half lives)

• Any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well being go the participant during any study procedures or the integrity of the data

• High Suicide Risk as determined by the Columbia Suicide Severity Rating Scale