Clinical trial NCT04249713: An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab
Official title: An Alternative Dose Interval Study to Examine Safety and Identify Potential Biomarkers in Participants With Hidradenitis Suppurativa Receiving Brodalumab
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Acne Inversa
Brodalumab
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Single Arm Study
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Biomarkers at Week 12
timeFrame: Week 12 compared with baseline.
measure: Biomarkers at Week 24
timeFrame: Week 24 compared with baseline.
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Week 0 to Week 24
Secondary outcomes:
measure: Clinical Response at Week 12 (as measured by HiSCR)
timeFrame: Week 12 compared with Baseline
measure: Clinical Response at Week 12 (as measured by modified Sartorius Score)
timeFrame: Week 12 compared with Baseline
measure: Clinical Response at Week 12 (as measured by IHS4)
timeFrame: Week 12 compared with Baseline
measure: Clinical Response at Week 24 (as measured by HiSCR)
timeFrame: Week 24 compared with Baseline
measure: Clinical Response at Week 24 (as measured by modified Sartorius Score)
timeFrame: Week 24 compared with Baseline
measure: Clinical Response at Week 24 (as measured by IHS4)
timeFrame: Week 24 compared with Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
Study officials:
affiliation: Rockefeller University
name: John W Frew, MD
role: PRINCIPAL_INVESTIGATOR
References: