Arthritis, PsoriaticPhase 3NCT07223138

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

A Phase 3 study testing Sonelokimab in people with Arthritis, Psoriatic, run by MoonLake Immunotherapeutics AG at 17 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthritis, Psoriatic
What is being tested?: Sonelokimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,560 participants
Where: 17 sitesUnited States
Study dates: 13 Nov 2025to 4 Feb 2028
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Clinical Site
Avon Park, Florida, 33825
Clinical Site
Avondale, Arizona, 85392
Clinical Site
Baytown, Texas, 77521
Clinical Site
Charlotte, North Carolina, 28262
Clinical Site
Clearwater, Florida, 33765
Clinical Site
Duncansville, Pennsylvania, 16635
Clinical Site
Jonesboro, Arkansas, 72401
Clinical Site
Leland, North Carolina, 28451
Clinical Site
Lubbock, Texas, 79424
Clinical Site
Memphis, Tennessee, 38119
Clinical Site
Mesa, Arizona, 85210
Clinical Site
Middleburg Heights, Ohio, 44130
Clinical Site
Phoenix, Arizona, 85032
Clinical Site
Scottsdale, Arizona, 85260
Clinical Site
Tampa, Florida, 33607
Clinical Site
Tucson, Arizona, 85748
Clinical Site
Upland, California, 91786

Other trials in United States

About this study

Read the detailed description

M1095-PSA-303 is a Phase 3, multicenter, open-label extension study to investigate the long-term safety, tolerability and clinical efficacy of sonelokimab 60 mg subcutaneously every 4 weeks in patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302).

Conditions: Arthritis, Psoriatic
Being tested: Sonelokimab
Keywords: Anti-Inflammatory Agents, Sonelokimab, Nanobody, Psoriatic Arthritis
Medical subject headings: Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SonelokimabDrug
Open-label

Study groups in NCT07223138
Study group	Role	What they receive
Experimental: sonelokimab dose	Experimental	All participants will receive sonelokimab subcutaneously every 4 weeks Receives: Drug: Sonelokimab

What is being measured

The primary outcome is the main question the study is designed to answer.

Long-term safety and tolerability of sonelokimab:
Treatment-emergent adverse events (TEAEs)
Measured: 52 weeks
Long-term safety and tolerability of sonelokimab:
Serious adverse events (SAEs)
Measured: 52 weeks
Long-term safety and tolerability of sonelokimab:
TEAEs leading to study withdrawal
Measured: 52 weeks
Long-term safety and tolerability of sonelokimab:
Adverse events of special interest (AESIs)
Measured: 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
Measured: 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
Measured: 52 weeks

Secondary outcomes (10)

Long-term efficacy of sonelokimab:
Proportion of participants achieving American College of Rheumatology (ACR) 20/50/70% improvement criteria over time
Measured: 52 weeks
Long-term efficacy of sonelokimab:
Change over time in Minimal disease activity (MDA)
Measured: 52 weeks
Long-term efficacy of sonelokimab:
Change over time in Health assessment questionnaire-disability index (HAQ-DI)
Measured: 52 weeks
Long-term efficacy of sonelokimab:
Change over time in Tender joint count (TJC)68/ swollen joint count (SJC)66
Measured: 52 weeks
Long-term efficacy of sonelokimab:
Proportion of participants achieving Psoriasis Area and Severity Index (PASI) 75/90/100 over time
Measured: 52 weeks
Long-term efficacy of sonelokimab:
Change over time in Modified Nail Psoriasis Severity Index (mNAPSI)
Measured: 52 weeks
Long-term efficacy of sonelokimab:
Proportion of participants achieving Very low disease activity (VLDA) over time
Measured: 52 weeks
Long-term efficacy of sonelokimab:
Proportion of participants achieving SpondyloArthritis Research Consortium of Canada (SPARCC) over time
Measured: 52 weeks
Long-term efficacy of sonelokimab:
Change over time in Leeds Enthesitis Index (LEI)
Measured: 52 weeks
Long term efficacy of sonelokimab
Proportion of participants achieving both an ACR 50/ACR70 and PASI90/100 improvement over time
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 20254 Feb 2028

First posted31 Oct 2025
Study start13 Nov 2025
Primary completion4 Feb 2028 (estimated)
Study completion4 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,560 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07223138
Sponsor's protocol ID: M1095-PSA-303
Other IDs: IZAR-OLE
Status last verified: Sep 2026
First submitted: 20 Oct 2025
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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