ATI-450 vs Placebo in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

Study Overview
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Brief Summary
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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).

Detailed Description
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This is a Phase 2a, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

Official Title
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A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATI-450 vs Placebo in Patients With Moderate to Severe HS

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: ATI-450
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to comprehend and be willing to sign the Institutional Review Board (IRB)-approved patient informed consent form prior to administration of any study-related procedures. Patient 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: Patient has a history of active skin disease other than HS that could interfere with the assessment of HS. Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, e.g., previous malignancy, previous venous thromboembolism. Patient 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATI-450<br>ATI-450 50mg oral tablet BID | Drug: ATI-450<br>* Oral, small molecule MK2 inhibitor<br>* Other names: Zunsemetinib;|
| Experimental: Placebo<br>Placebo oral tablet BID | Drug: Placebo oral tablet<br>* Placebo tablet manufactured to match ATI-450 in appearance<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy measured as the change from Baseline in inflammatory nodule/abscess count at Week 12. |  | Baseline through Week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. |  | Baseline through Week 12. | 
| Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) over time for the 12-week treatment period. |  | Baseline through Week 12. | 
| Percentage of patients achieving at least a 30% reduction and at least 1 unit reduction from Baseline in the numerical rating scale (NRS30) in Patient's Global Assessment of Skin Pain at Week 12 among patients with Baseline NRS ≥3. |  | Baseline through Week 12. | 
| Change from Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) over time for the 12-week treatment period |  | Baseline through Week 12. | 
| Change from Baseline in Dermatology Life Quality Index (DLQI) over time for the 12-week treatment period |  | Baseline through Week 12. | 
| Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities |  | Baseline through Week 12. | 
| To assess trough and 2 hour concentrations of ATI-450 and its metabolite |  | Day 1, 8, and 85 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hidradenitis, Suppurativa, HS, Acne inversa