Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

Hidradenitis Suppurativa Clinical Trial

Official title:

A Pilot Study of Safety and Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960268
• Other study ID #: JFR-0989
• Status: Completed
• Phase: Early Phase 1
• Start date: May 28, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Phase 0, Open Label study of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every 2 weeks for 24 weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of Brodalumab) to assess for safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Confirmed Diagnosis of Hidradenitis Suppurativa by the PI

• Age 18 or older

• Moderate to Severe Hidradenitis Suppurativa as determined by the PI

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

• History of Keloid Scarring

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Brodalumab
interleukin 17 receptor A antagonist

Locations

Country	Name	City	State
United States	Rockefeller Unviersity	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	Valeant Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 measured in pg/mL	Week 12 compared with baseline.
Primary	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 measured in pg/mL	Week 24 compared with baseline.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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