What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis include TNF-alpha inhibitors (e.g., etanercept, infliximab), IL-12/23 inhibitors (e.g., ustekinumab), and IL-17 inhibitors (e.g., secukinumab, ixekizumab). Known side effects of TNF-alpha inhibitors include increased risk of infections, injection site reactions, and potential cardiovascular benefits. IL-12/23 inhibitors like ustekinumab may cause serious infections, nasopharyngitis, and headache. IL-17 inhibitors can lead to similar infections, injection site reactions, and nasopharyngitis. Monitoring for infections and other adverse events is crucial during treatment.

What prior FDA approvals exist?

FDA-approved treatments for Psoriatic Arthritis include TNF inhibitors such as etanercept, adalimumab, infliximab, certolizumab pegol, and golimumab. Other approved cytokine inhibitors include ustekinumab (anti-IL-12/23) and secukinumab and ixekizumab (both anti-IL-17). While the context does not provide specific information on drugs targeting the MK2 pathway like ATI-450, these biologic agents and kinase inhibitors represent the current landscape of PsA treatments.

What other types of research exist?

Promising novel alternatives to ATI-450 for Psoriatic Arthritis patients include: 1) Ixekizumab, an IL-17A inhibitor, which has shown long-term efficacy and safety in patients with inadequate response to TNF inhibitors. 2) Secukinumab, another IL-17A inhibitor, which has demonstrated significant improvement in joint and skin symptoms. 3) Upadacitinib, a JAK inhibitor, which has shown efficacy in patients with an inadequate response to NSAIDs and TNF inhibitors. These treatments offer different mechanisms of action and have been validated in recent clinical trials.

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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 up to 5 years

Summary

This trial is testing a new drug called ATI-450 to see if it can help people with moderate to severe psoriatic arthritis. The study will check how the drug moves through and affects the body, its safety, and if it can reduce symptoms. The goal is to find a new treatment option for those who have serious symptoms and may not respond well to current treatments.

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.

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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 2 trial • 25 Patients • NCT04247815

13%

Urinary tract infection

COVID-19 pneumonia

Ligament sprain

Skin abrasion

Blood cholesterol increased

Blood pressure increased

Low density lipoprotein increased

Hypokalemia

Electrocardiogram abnormal

Essential hypertension

White blood cell count increased

Blood creatine phosphokinase increased

Ear infection

Sinusitis

Rash erythematous

Palpitations

Ventricular extrasystoles

Dental caries

Constipation

Mouth ulceration

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Psoriatic Arthritis (PsA) target specific cytokines and immune pathways to reduce inflammation and prevent joint damage. The ATI-450 trial focuses on selective inhibition of the MAPK-activated protein kinase 2 (MK2) pathway, which plays a role in inflammatory responses. Other treatments include TNF inhibitors (e.g., etanercept, infliximab) that block tumor necrosis factor-alpha (TNF-α), IL-12/23 inhibitors (e.g., ustekinumab), and IL-17 inhibitors (e.g., secukinumab), which target specific interleukins involved in the immune response. These treatments are essential for PsA patients as they help manage symptoms, reduce inflammation, and prevent joint damage, thereby improving their quality of life.

Treating axial and peripheral spondyloarthritis, including psoriatic arthritis, to target: results of a systematic literature search to support an international treat-to-target recommendation in spondyloarthritis.