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

Rockefeller University

Status and phase: Withdrawn; Early Phase 1

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Brodalumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04249713

JFR-0999

Details and patient eligibility

About

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.

Full description

Phase 0, Open Label study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every week for 24 weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of Brodalumab) to assess for safety.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Brodalumab

Experimental group

Description:

Brodalumab 210mg subcutaneously every week for 24 weeks

Treatment:

Drug: Brodalumab