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

Aclaris Therapeutics, Inc.95 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

ATI-450DRUG

Oral, small molecule MK2 inhibitor

Placebo oral tabletDRUG

Placebo tablet manufactured to match ATI-450 in appearance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (20)

Aclaris Investigational Site

Birmingham, Alabama, United States

Aclaris Investigational Site

Outcomes

Primary Outcomes

Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12

AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.

Time frame: Baseline, Week 12

Secondary Outcomes

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12

HiSCR50 Achiever was defined as a participant having a ≥50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase in the number of abscesses, and no increase in the number of draining fistula counts from baseline. A participant was considered an achiever only if all 3 criteria mentioned above were fulfilled. Model-based estimates and 90% confidence intervals (CIs) were produced. Firth's penalized likelihood logistic regression model with fixed effects for treatment and baseline count of inflammatory abscesses and nodules was used.

Time frame: Week 12

Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12

The IHS-4 is a validated tool used to access the HS severity and is calculated based on the clinical signs of HS: inflammatory nodules, abscesses and draining tunnels (fistulas and sinuses). The IHS-4 score = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels \[fistulas/sinuses\] multiplied by 4). Mild HS is a score of 3 or less, moderate HS is a score of 4-10, and severe HS is a score of 11 or higher. A decrease in score means less severity.

Time frame: Baseline, Week 12

Percentage of Participants Achieving NRS30

NRS30 Achiever was defined as participants achieving at least a 30% reduction from baseline in Patient's Global Assessment of Skin Pain (PGA-SP) and at least 1 unit reduction from baseline in PGA-SP at Week 12 among participants with baseline PGA-SP ≥3. Model-based estimates and 90% CIs were produced. Firth's penalized likelihood logistic regression model with fixed effects for treatment and baseline PGA-SP was used.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12

The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of questions including a single "yes/no" question and questions with possible responses of "not at all," "a little," "a lot," or "very much." These questions evaluate the impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each question was scored using a 4-point scale ranging from 0 to 3 based on a participant's response: not at all/not relevant (0), a little (1), a lot (2) and very much (3). The total score of the DLQI ranged from 0 to 30 and was calculated by adding up the scores from each question. The higher the score, the greater the impact on a participant's QoL.

Time frame: Baseline, Week 12