Status:
COMPLETED
ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Lead Sponsor:
Aclaris Therapeutics, Inc.
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a Phase 2a study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (H...
Eligibility Criteria
Inclusion
- Able to comprehend and be willing to sign the Institutional Review Board (IRB)-approved participant informed consent form prior to administration of any study-related procedures.
- Participant must have stable HS.
- Total abscesses and/or nodule (AN) count of ≥5 at Baseline visit.
- HS lesions present in at least 2 distinct anatomical areas at Screening and Baseline.
Exclusion
- Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
- Participant has an uncontrolled non-immunoinflammatory disease that may place the participant at increased risk during the study or impact the interpretation of results, e.g., previous malignancy, previous venous thromboembolism.
- Participant has experience with \>2 biologics, \>1 Janus kinase (JAK) inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor.
- Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the Screening visit.
Key Trial Info
Start Date :
December 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2023
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05216224
Start Date
December 29 2021
End Date
January 24 2023
Last Update
January 7 2026
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Aclaris Investigational Site
Birmingham, Alabama, United States, 35244
2
Aclaris Investigational Site
Fort Smith, Arkansas, United States, 72916
3
Aclaris Investigational Site
Encino, California, United States, 91436
4
Aclaris Investigational Site
San Francisco, California, United States, 94115