Clinical trial NCT05216224: ATI-450 vs Placebo in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis
Suppurativa
HS
Acne inversa
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled study
Primary purpose: TREATMENT

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 (HS).

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy measured as the change from Baseline in inflammatory nodule/abscess count at Week 12.
timeFrame: Baseline through Week 12.
Secondary outcomes:
measure: Percentage of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
timeFrame: Baseline through Week 12.
measure: Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) over time for the 12-week treatment period.
timeFrame: Baseline through Week 12.
measure: 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.
timeFrame: Baseline through Week 12.
measure: Change from Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) over time for the 12-week treatment period
timeFrame: Baseline through Week 12.
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) over time for the 12-week treatment period
timeFrame: Baseline through Week 12.
measure: Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities
timeFrame: Baseline through Week 12.
measure: To assess trough and 2 hour concentrations of ATI-450 and its metabolite
timeFrame: Day 1, 8, and 85
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Aclaris Investigational Site
state: Alabama
city: Fort Smith
country: United States
facility: Aclaris Investigational Site
state: Arkansas
city: Encino
country: United States
facility: Aclaris Investigational Site
state: California
city: San Francisco
country: United States
facility: Aclaris Investigational Site
state: California
city: Thousand Oaks
country: United States
facility: Aclaris Investigational Site
state: California
city: Boca Raton
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Tampa
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Marietta
country: United States
facility: Aclaris Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Aclaris Investigational Site
state: Georgia
city: Metairie
country: United States
facility: Aclaris Investigational Site
state: Louisiana
city: Fort Gratiot
country: United States
facility: Aclaris Investigational Site
state: Michigan
city: Charlotte
country: United States
facility: Aclaris Investigational Site
state: North Carolina
city: Athens
country: United States
facility: Aclaris Investigational Site
state: Ohio
city: Mason
country: United States
facility: Aclaris Investigational Site
state: Ohio
city: Hershey
country: United States
facility: Aclaris Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Aclaris Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Aclaris Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Aclaris Investigational Site
state: Texas
Study officials:
affiliation: Aclaris Therapeutics, Inc.
name: Ajay Aggarwal
role: STUDY_DIRECTOR
References: