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Monoclonal Antibodies

Sonelokimab for Psoriatic Arthritis

Phase 2

Waitlist Available

Research Sponsored by MoonLake Immunotherapeutics AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is ≥18 years of age

Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, 4, 8, 12

Awards & highlights

Study Summary

This trial tests a new drug to treat psoriatic arthritis, compared to a placebo and a reference drug.

Who is the study for?

Adults over 18 with active psoriatic arthritis, meeting specific joint count criteria and diagnosed per CASPAR guidelines. They must have had symptoms for at least 6 months, no rheumatoid factor or anti-CCP antibodies present, suitable for adalimumab treatment, and a history of psoriasis. Excluded are those with other chronic inflammatory conditions, certain types of severe arthritis, failure on anti-IL-17 or more than two biologic treatments for PsA, or allergies to trial drugs.Check my eligibility

What is being tested?

The trial is testing the effectiveness and safety of Sonelokimab given under the skin compared to a placebo in treating psoriatic arthritis. Adalimumab is used as an active reference drug to compare results against known outcomes.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site (like pain or swelling), increased risk of infections due to immune system suppression by both Sonelokimab and Adalimumab, allergic reactions if sensitive to ingredients in these medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have active disease with at least 3 tender and 3 swollen joints.

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I have active psoriasis or a dermatologist-confirmed history of it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, 4, 8, 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2, 4, 8, 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, 4, 8, 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

Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)

Secondary outcome measures

Leeds Dactylitis Index (LDI)

Leeds Enthesitis Index (LEI)

Modified Nail Psoriasis Severity Index (mNAPSI)

+4 more

Side effects data

From 2013 Phase 4 trial • 50 Patients • NCT01644396

LATENT TUBERCULOSIS

RHINITIS

ORAL HERPES

RESPIRATORY TRACT INFECTION

CONTUSION

EXCORIATION

ASPARTATE AMINOTRANSFERASE INCREASED

BLOOD GLUCAGON INCREASED

BLOOD TRIGLYCERIDES INCREASED

RENAL COLIC

EPISTAXIS

URTICARIA

ANAEMIA

FURUNCLE

HERPES SIMPLEX

ALANINE AMINOTRANSFERASE INCREASED

100%

80%

60%

40%

20%

Study treatment Arm

Adalimumab

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: sonelokimab dose regimen 3Experimental Treatment1 Intervention

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3

Group II: sonelokimab dose regimen 2Experimental Treatment1 Intervention

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2

Group III: sonelokimab dose regimen 1Experimental Treatment1 Intervention

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1

Group IV: adalimumabActive Control1 Intervention

Subjects randomized to this arm will receive adalimumab

Group V: PlaceboPlacebo Group1 Intervention

Subjects randomized to this arm will receive placebo

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

MoonLake Immunotherapeutics AGLead Sponsor

1 Previous Clinical Trials

234 Total Patients Enrolled

Kristian Reich, M.D., Ph.D. (equ.)Study DirectorMoonLake Immunotherapeutics AG

Media Library

Sonelokimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05640245 — Phase 2

Psoriatic Arthritis Research Study Groups: adalimumab, Placebo, sonelokimab dose regimen 1, sonelokimab dose regimen 2, sonelokimab dose regimen 3

Psoriatic Arthritis Clinical Trial 2023: Sonelokimab Highlights & Side Effects. Trial Name: NCT05640245 — Phase 2

Sonelokimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05640245 — Phase 2

Frequently Asked Questions

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

Has the second dosage level of sonelokimab been approved by the U.S. Food and Drug Administration?

"After careful consideration, our team at Power has determined that the safety of sonelokimab dose regimen 2 is ranked a 2. This evaluation was based on Phase 2 trial data which, while confirming its safety, has not yet established efficacy."

Answered by AI

Is there still an opportunity to enroll in this research protocol?

"According to clinicaltrials.gov, this research initiative is no longer actively recruiting patients. The project was initially posted on December 1st 2022 and the last update occurred November 28th of the same year. Nonetheless, there are currently 375 other trials that are open for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

2022. "Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05640245.

All > Psoriatic Arthritis