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

NCT04249713 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: JFR-0999
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Acne Inversa; Brodalumab

Outcome Measures

Primary Outcomes (3)

• Biomarkers at Week 12

  Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL

  Week 12 compared with baseline.

• Biomarkers at Week 24

  Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL

  Week 24 compared with baseline.

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Incidence of Grade 2/3 adverse events during the study

  Week 0 to Week 24

Secondary Outcomes (6)

• Clinical Response at Week 12 (as measured by HiSCR)

  Week 12 compared with Baseline

• Clinical Response at Week 12 (as measured by modified Sartorius Score)

  Week 12 compared with Baseline

• Clinical Response at Week 12 (as measured by IHS4)

  Week 12 compared with Baseline

• Clinical Response at Week 24 (as measured by HiSCR)

  Week 24 compared with Baseline

• Clinical Response at Week 24 (as measured by modified Sartorius Score)

  Week 24 compared with Baseline

Study Arms (1)

Brodalumab

EXPERIMENTAL

Brodalumab 210mg subcutaneously every week for 24 weeks

Drug: Brodalumab

Interventions

Brodalumab DRUG

Interleukin 17 Receptor A Antagonist

Also known as: Siliq

Brodalumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• John W Frew, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label Single Arm Study

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: February 3, 2020
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)