Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa
Detailed Description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adult participants with hidradenitis suppurativa (HS). This stu...
Eligibility Criteria
Inclusion
- Clinically confirmed diagnosis of active HS with a disease duration of greater than or equal to (≥) 6 months before Day 1.
- HS lesions present in at least 2 distinct anatomical areas.
- Total Abscess and inflammatory nodule (AN) count ≥ 5.
- Draining fistulas less than or equal to (≤) 20.
- Stable HS for at least 6 weeks prior to Day 1 visit.
Exclusion
- 1\. Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the participant's response to therapy.
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2022
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04856930
Start Date
July 7 2021
End Date
December 14 2022
Last Update
September 22 2025
Active Locations (34)
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1
Site 10-108
Birmingham, Alabama, United States, 35224
2
Site 10-104
Fountain Valley, California, United States, 92708
3
Site 10-119
Northridge, California, United States, 91324
4
Site 10-102
Sacramento, California, United States, 95817