Phase 2
N=95
ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT05216224 ↗Enrolled (actual)
95
Serious AEs
1.1%
Results posted
Jan 2026
Primary outcome: Primary: Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12 — -2.93; -5.94 AN count — p=>0.999
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ATI-450 (Drug); Placebo oral tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aclaris Therapeutics, Inc.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12 |
-2.93; -5.94 | >0.999 |
| SECONDARY Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12 |
31.5; 51.4 | — |
| SECONDARY Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12 |
-4.01; -11.86 | — |
| SECONDARY Percentage of Participants Achieving NRS30 |
43.7; 57.5 | — |
| SECONDARY Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) at Week 12 |
-0.31; -0.73 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12 |
-3.27; -4.08 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
35; 26 | — |
| SECONDARY ATI-450 and Metabolite (CDD-2164) Concentrations |
144.995; 0.623; 207.571; 0.504; 232.110; 0.250 | — |
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 (HS).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05216224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.