An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Early Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brodalumab Brodalumab 210mg subcutaneously every week for 24 weeks |
Drug: Brodalumab
Interleukin 17 Receptor A Antagonist
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Biomarkers at Week 12 [Week 12 compared with baseline.]
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL
- Biomarkers at Week 24 [Week 24 compared with baseline.]
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Week 0 to Week 24]
Incidence of Grade 2/3 adverse events during the study
Secondary Outcome Measures
- Clinical Response at Week 12 (as measured by HiSCR) [Week 12 compared with Baseline]
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
- Clinical Response at Week 12 (as measured by modified Sartorius Score) [Week 12 compared with Baseline]
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.
- Clinical Response at Week 12 (as measured by IHS4) [Week 12 compared with Baseline]
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)
- Clinical Response at Week 24 (as measured by HiSCR) [Week 24 compared with Baseline]
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
- Clinical Response at Week 24 (as measured by modified Sartorius Score) [Week 24 compared with Baseline]
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.
- Clinical Response at Week 24 (as measured by IHS4) [Week 24 compared with Baseline]
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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rockefeller University Hospital | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Rockefeller University
Investigators
- Principal Investigator: John W Frew, MD, Rockefeller University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JFR-0999