ATI-450 for Psoriatic Arthritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Aclaris Investigational Site, Miami Lakes, FL
Psoriatic Arthritis+2 More
ATI-450 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Psoriatic Arthritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Psoriatic Arthritis

Study Objectives

1 Primary · 26 Secondary · Reporting Duration: Baseline to Week 12

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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Psoriatic Arthritis

Trial Design

2 Treatment Groups

ATI-450
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

70 Total Participants · 2 Treatment Groups

Primary Treatment: ATI-450 · Has Placebo Group · Phase 2

ATI-450
Drug
Experimental Group · 1 Intervention: ATI-450 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATI-450
2020
Completed Phase 2
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 12
Closest Location: Aclaris Investigational Site · Miami Lakes, FL
2019First Recorded Clinical Trial
1 TrialsResearching Psoriatic Arthritis
15 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have active plaque psoriasis or documented history of plaque psoriasis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.