A Phase 2 interventional study of ATI-450 and Placebo Oral Tablet in Psoriatic Arthritis, sponsored by Aclaris Therapeutics, Inc.. Terminated at 22 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Aclaris Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
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.
600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.
This study's enrollment of 47 is below the median of 145 across 336 interventional studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →Aclaris Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient has moderate-to-severe PsA at Screening and Randomization Visits defined as
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ATI-450 50mg oral tablet BID
Drug: ATI-450
Placebo oral tablet BID
Drug: Placebo Oral Tablet
Oral, small molecule MK2 inhibitor
Also known as: CDD-450
Placebo tablet manufactured to match ATI-450 in appearance
Proportion of patients achieving ACR20 at Week 12
Time frame: Baseline to Week 12
Proportion of patients with ACR 50/70 at Week 12
Time frame: Baseline to Week 12
Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8
Time frame: Baseline to Week 12
Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12
Time frame: Baseline to Week 12
Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in Leeds Enthesitis Index over 12 weeks
Time frame: Baseline to Week 12
Change from baseline in Leeds Dactylitis Index over 12 weeks
Time frame: Baseline to Week 12
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
Time frame: Baseline to Week 12
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
Time frame: Baseline to Week 12
Proportion of patients achieving MDA at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Psoriasis Area Severity Index (PASI) 50/75/90 response (for patients with ≥3% body surface area psoriasis at baseline) at Week 12
Time frame: Baseline to Week 12
Mean change from baseline in PASI score at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12
Time frame: Baseline to Week 12
Type and frequency of adverse events
Time frame: Baseline to Week 12
Type and frequency of serious adverse events
Time frame: Baseline to Week 12
Zunsemetinib trough concentration ng/mL
Time frame: Baseline to Week 12
CDD-2164 metabolite trough concentration ng/mL
Time frame: Baseline to Week 12
Zunsemetinib peak concentration (Cmax) ng/mL
Time frame: Baseline to Week 12
CDD-2164 metabolite peak concentration (Cmax) ng/mL
Time frame: Baseline to Week 12
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zunsemetinib