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Small Molecule

ATI-450 for Psoriatic Arthritis

Phase 2
Waitlist Available
Research Sponsored by Aclaris Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights

Study Summary

This trial is testing a new drug, ATI-450, to see if it is effective, safe, and tolerated by patients with psoriatic arthritis. The trial will also look at the drug's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body).

Who is the study for?
This trial is for adults with moderate to severe Psoriatic Arthritis (PsA) who have at least 3 tender and swollen joints, a diagnosis of active plaque psoriasis or a history of it, and symptoms that started at least 6 months ago. People can't join if they had arthritis before age 17, have other immune diseases like lupus or rheumatoid arthritis, serious lab test issues, or uncontrolled diseases like cirrhosis.Check my eligibility
What is being tested?
The study compares the effects of ATI-450 versus a placebo in patients with PsA. It aims to assess how well ATI-450 works and its safety by looking at how the body processes it (pharmacokinetics/PK) and what it does to the body (pharmacodynamics/PD).See study design
What are the potential side effects?
While specific side effects for ATI-450 are not listed here, common side effects in trials like this may include gastrointestinal issues, headaches, fatigue, skin reactions at injection sites if applicable, and potential liver enzyme abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have at least 3 tender joints and 3 swollen joints during the screening and randomization visits.
Select...
You have active plaque psoriasis or have had it in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients achieving ACR20 at Week 12
Secondary outcome measures
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
+23 more

Side effects data

From 2021 Phase 2 trial • 25 Patients • NCT04247815
13%
Urinary tract infection
6%
COVID-19 pneumonia
6%
Low density lipoprotein increased
6%
Ventricular extrasystoles
6%
Ear infection
6%
Ligament sprain
6%
Constipation
6%
Sinusitis
6%
Blood cholesterol increased
6%
Palpitations
6%
Rash erythematous
6%
Dental caries
6%
Mouth ulceration
6%
Blood pressure increased
6%
White blood cell count increased
6%
Skin abrasion
6%
Blood creatine phosphokinase increased
6%
Electrocardiogram abnormal
6%
Hypokalemia
6%
Essential hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATI-450 Plus Methotrexate
Placebo Plus Methotrexate

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ATI-450Experimental Treatment1 Intervention
ATI-450 50mg oral tablet BID
Group II: PlaceboPlacebo Group1 Intervention
Placebo oral tablet BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATI-450
2020
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Aclaris Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
4,677 Total Patients Enrolled

Media Library

ATI-450 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05511519 — Phase 2
Psoriatic Arthritis Research Study Groups: ATI-450, Placebo
Psoriatic Arthritis Clinical Trial 2023: ATI-450 Highlights & Side Effects. Trial Name: NCT05511519 — Phase 2
ATI-450 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05511519 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study include elderly participants?

"As outlined in this clinical trial's requirements, the age range for partaking is 18 to 75."

Answered by AI

Has ATI-450 been granted regulatory clearance by the FDA?

"As this is a Phase 2 trial, meaning only limited safety data exists, ATI-450's safety was judged to be at level 2 on our scale."

Answered by AI

How many participants are in the cohort associated with this research?

"Affirmative. Clinicaltrials.gov's information indicates that this medical trial is actively recruiting patients; it was initially posted on July 12th 2022 and last modified on August 19th 2022. The study requires 70 participants to be recruited from 8 clinical sites."

Answered by AI

How many treatment centers are presently engaged in this research endeavor?

"Currently, this trial is operational at 8 sites spanning Miami Lakes, Tampa and Freehold. To reduce the burden of travel for participants, it is recommended to pick a site closest to your location."

Answered by AI

Who is eligible to enroll in this clinical trial?

"This experiment seeks to recruit 70 patients with psoriatic arthritis ranging from 18 to 75 years old. In order be eligible, they must have experienced symptoms for at least 6 months prior and meet the Classification Criteria for PsA, which includes having ≥3 tender joints (68 joint count), ≥3 swollen joints (66 joint count) and a diagnosis of active plaque psoriasis or documented history thereof."

Answered by AI

Are there any openings remaining for this research endeavor?

"Affirmative. Clinicaltrials.gov's records confirm that this medical investigation, which was initially posted on July 12th 2022, is actively seeking recruits. Approximately 70 participants must be sourced from 8 distinct healthcare centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis
2022. "Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05511519.
~17 spots leftby Apr 2025
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