A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis

NCT07223138 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 2 other identifiers: M1095-PSA-303IZAR-OLE
• Study Type: interventional
• Target: 1,560
• Locations: 1 country
• Sites: 10

Brief Summary

This is a study to demonstrate the long-term safety, tolerability and clinical efficacy of sonelokimab in the treatment of patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302)

Conditions

Arthritis, Psoriatic

Keywords

Anti-Inflammatory Agents; Sonelokimab; Nanobody; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (6)

• Long-term safety and tolerability of sonelokimab:

  Treatment-emergent adverse events (TEAEs)

  52 weeks

• Long-term safety and tolerability of sonelokimab:

  Serious adverse events (SAEs)

  52 weeks

• Long-term safety and tolerability of sonelokimab:

  TEAEs leading to study withdrawal

  52 weeks

• Long-term safety and tolerability of sonelokimab:

  Adverse events of special interest (AESIs)

  52 weeks

• Long-term safety and tolerability of sonelokimab:

  Clinically significant changes in vital signs and standard 12-lead electrocardiogram Measure description: Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline

  52 weeks

• Long-term safety and tolerability of sonelokimab:

  Clinically significant changes in clinical laboratory parameters Measure description: Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline

  52 weeks

Secondary Outcomes (10)

• Long-term efficacy of sonelokimab:

  52 weeks

• Long-term efficacy of sonelokimab:

  52 weeks

• Long-term efficacy of sonelokimab:

  52 weeks

• Long-term efficacy of sonelokimab:

  52 weeks

• Long-term efficacy of sonelokimab:

  52 weeks

Study Arms (1)

Experimental: sonelokimab dose

EXPERIMENTAL

All participants will receive sonelokimab subcutaneously every 4 weeks

Drug: Sonelokimab

Interventions

Sonelokimab DRUG

Open-label

Experimental: sonelokimab dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study.
• Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the end-of-treatment visit of the parental study.
• Participants must have received their last dose of study treatment in the parental study no more than 8 weeks (but ideally 4 weeks) before the first dose in this OLE study.
• Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment.
• Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.

You may not qualify if:

• Participants who met any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
• Participants who have ongoing or planned use of one or more of the prohibited PsA or non-PsA treatments specified in this protocol.
• Participants who plan to participate in another interventional study for a drug or device during this study.
• Participants who were unblinded during the parental study.
• Participant noncompliance to the parental study

Sponsors & Collaborators

• MoonLake Immunotherapeutics AG: lead

Study Sites (10)

Clinical Site

Mesa, Arizona, 85210, United States

Location

Clinical Site

Phoenix, Arizona, 85032, United States

Location

Clinical Site

Jonesboro, Arkansas, 72401, United States

Location

Clinical Site

Upland, California, 91786, United States

Location

Clinical Site

Avon Park, Florida, 33825, United States

Location

Clinical Site

Clearwater, Florida, 33765, United States

Location

Clinical Site

Middleburg Heights, Ohio, 44130, United States

Location

Clinical Site

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Site

Memphis, Tennessee, 38119, United States

Location

Clinical Site

Lubbock, Texas, 79424, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

sonelokimab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 31, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): February 4, 2028
• Study Completion (Estimated): February 4, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (10)