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

An Alternative Dose Interval Study to Examine Safety and Identify Potential Biomarkers in Participants With Hidradenitis Suppurativa Receiving Brodalumab

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.

Study Overview

• Status: Withdrawn
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Brodalumab

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.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Rockefeller University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Brodalumab; Brodalumab 210mg subcutaneously every week for 24 weeks	Drug: Brodalumab; Interleukin 17 Receptor A Antagonist; Other Names: Siliq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Grade 2/3 adverse events during the study	Week 0 to Week 24
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response at Week 12 (as measured by HiSCR)	Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 12 when compared with baseline	Week 12 compared with Baseline
Clinical Response at Week 12 (as measured by modified Sartorius Score)	Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is <5 cm; 3 points when it is 5-10 cm; and 9 points when it is >10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.	Week 12 compared with Baseline
Clinical Response at Week 12 (as measured by IHS4)	Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)	Week 12 compared with Baseline
Clinical Response at Week 24 (as measured by HiSCR)	Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 24 when compared with baseline	Week 24 compared with Baseline
Clinical Response at Week 24 (as measured by modified Sartorius Score)	Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is <5 cm; 3 points when it is 5-10 cm; and 9 points when it is >10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.	Week 24 compared with Baseline
Clinical Response at Week 24 (as measured by IHS4)	Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)	Week 24 compared with Baseline

Collaborators and Investigators

• Sponsor: Rockefeller University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 3, 2020
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Hidradenitis Suppurativa; Acne Inversa; Brodalumab
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: JFR-0999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No