Clinical trial NCT05511519: Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zunsemetinib vs Placebo in Patients With Moderate-to-Severe Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Arthritis
Psoriatic
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2a study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.

Detailed description: This is a Phase 2a, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PsA with symptom onset at least 6 months before the Screening Visit and fulfilment of the Classification Criteria for PsA.
* Patient has moderate-to-severe PsA at Screening and Randomization Visits defined as

  * ≥3 tender joints (based on 68 joint counts) and
  * ≥3 swollen joints (based on 66 joint counts).
* Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.

Exclusion Criteria:

* Any arthritis with onset before age 17 years, or current diagnosis of inflammatory joint disease other than PsA, or other immunological disease (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).
* Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, eg, cirrhosis, previous malignancy, previous venous thromboembolism.
* Any clinically significant laboratory abnormality that would affect interpretation of study data or safety of the patient's participation in the study, per judgment of the investigator.

Primary outcomes:
measure: Proportion of patients achieving ACR20 at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Proportion of patients with ACR 50/70 at Week 12
timeFrame: Baseline to Week 12
measure: Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8
timeFrame: Baseline to Week 12
measure: Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in Leeds Enthesitis Index over 12 weeks
timeFrame: Baseline to Week 12
measure: Change from baseline in Leeds Dactylitis Index over 12 weeks
timeFrame: Baseline to Week 12
measure: Proportion 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 Daily Assessment of Skin Pain at Weeks 2, 4, 8, 12 among patients with Baseline NRS ≥3
timeFrame: Baseline to Week 12
measure: Proportion of patients achieving a sIGA of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline among those with a baseline investigator's global assessment of at least 3 over 12 weeks
timeFrame: Baseline to Week 12
measure: Proportion of patients achieving MDA at weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Psoriasis Area Severity Index (PASI) 50/75/90 response (for patients with ≥3% body surface area psoriasis at baseline) at Week 12
timeFrame: Baseline to Week 12
measure: Mean change from baseline in PASI score at weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12
timeFrame: Baseline to Week 12
measure: Type and frequency of adverse events
timeFrame: Baseline to Week 12
measure: Type and frequency of serious adverse events
timeFrame: Baseline to Week 12
measure: Zunsemetinib trough concentration ng/mL
timeFrame: Baseline to Week 12
measure: CDD-2164 metabolite trough concentration ng/mL
timeFrame: Baseline to Week 12
measure: Zunsemetinib peak concentration (Cmax) ng/mL
timeFrame: Baseline to Week 12
measure: CDD-2164 metabolite peak concentration (Cmax) ng/mL
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Tampa
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Freehold
country: United States
facility: Aclaris Clinical Operations
state: New Jersey
city: Charlotte
country: United States
facility: Aclaris Clinical Operations
state: North Carolina
city: Perrysburg
country: United States
facility: Aclaris Investigational Site
state: Ohio
city: Duncansville
country: United States
facility: Aclaris Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Aclaris Investigational Site
state: Tennessee
city: Mesquite
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Białystok
country: Poland
facility: Aclaris Investigational Site
city: Bydgoszcz
country: Poland
facility: Aclaris Investigational Site
city: Częstochowa
country: Poland
facility: Aclaris Investigational Site
city: Katowice
country: Poland
facility: Aclaris Investigational Site
city: Katowice
country: Poland
facility: Aclaris Investigational Site
city: Kraków
country: Poland
facility: Aclaris Investigational Site
city: Kraków
country: Poland
facility: Aclaris Investigational Site
city: Olsztyn
country: Poland
facility: Aclaris Investigational Site
city: Poznań
country: Poland
facility: Aclaris Investigational Site
city: Stalowa Wola
country: Poland
facility: Aclaris Investigational Site
city: Szczecin
country: Poland
facility: Aclaris Investigational Site
city: Toruń
country: Poland
facility: Aclaris Investigational Site
city: Warszawa
country: Poland
facility: Aclaris Investigational Site
city: Wrocław
country: Poland
facility: Aclaris Investigational Site
Study officials:
References: