Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05511519
• Other study ID #: ATI-450-PsA-201
• Status: Terminated
• Phase: Phase 2
• Start date: July 12, 2022
• Est. completion date: January 3, 2024

Study information

• Verified date: April 2024
• Source: Aclaris Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: January 3, 2024
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• ATI-450
Oral, small molecule MK2 inhibitor
• Placebo Oral Tablet
Placebo tablet manufactured to match ATI-450 in appearance

Locations

Country	Name	City	State
Poland	Aclaris Investigational Site	Bialystok
Poland	Aclaris Investigational Site	Bydgoszcz
Poland	Aclaris Investigational Site	Czestochowa
Poland	Aclaris Investigational Site	Katowice
Poland	Aclaris Investigational Site	Katowice
Poland	Aclaris Investigational Site	Kraków
Poland	Aclaris Investigational Site	Kraków
Poland	Aclaris Investigational Site	Olsztyn
Poland	Aclaris Investigational Site	Poznan
Poland	Aclaris Investigational Site	Stalowa Wola
Poland	Aclaris Investigational Site	Szczecin
Poland	Aclaris Investigational Site	Torun
Poland	Aclaris Investigational Site	Warszawa
Poland	Aclaris Investigational Site	Wroclaw
United States	Aclaris Clinical Operations	Charlotte	North Carolina
United States	Aclaris Investigational Site	Duncansville	Pennsylvania
United States	Aclaris Clinical Operations	Freehold	New Jersey
United States	Aclaris Investigational Site	Memphis	Tennessee
United States	Aclaris Investigational Site	Mesquite	Texas
United States	Aclaris Investigational Site	Miami Lakes	Florida
United States	Aclaris Investigational Site	Perrysburg	Ohio
United States	Aclaris Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aclaris Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving ACR20 at Week 12		Baseline to Week 12
Secondary	Proportion of patients with ACR 50/70 at Week 12		Baseline to Week 12
Secondary	Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8		Baseline to Week 12
Secondary	Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12		Baseline to Week 12
Secondary	Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in Leeds Enthesitis Index over 12 weeks		Baseline to Week 12
Secondary	Change from baseline in Leeds Dactylitis Index over 12 weeks		Baseline to Week 12
Secondary	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		Baseline to Week 12
Secondary	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		Baseline to Week 12
Secondary	Proportion of patients achieving MDA at weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Psoriasis Area Severity Index (PASI) 50/75/90 response (for patients with =3% body surface area psoriasis at baseline) at Week 12		Baseline to Week 12
Secondary	Mean change from baseline in PASI score at weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12		Baseline to Week 12
Secondary	Type and frequency of adverse events		Baseline to Week 12
Secondary	Type and frequency of serious adverse events		Baseline to Week 12
Secondary	Zunsemetinib trough concentration ng/mL		Baseline to Week 12
Secondary	CDD-2164 metabolite trough concentration ng/mL		Baseline to Week 12
Secondary	Zunsemetinib peak concentration (Cmax) ng/mL		Baseline to Week 12
Secondary	CDD-2164 metabolite peak concentration (Cmax) ng/mL		Baseline to Week 12