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ACTIVE NOT RECRUITINGPhase3

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

Sponsor: MoonLake Immunotherapeutics AG

NCT ID: NCT06641089

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sonelokimab (drug), Placebo (drug), Risankizumab (drug)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
Sonelokimab — drug: Sonelokimab · Placebo — drug: Placebo · Risankizumab — drug: Active comparator
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
600
Started
2024-10-15
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for arthritis, psoriatic
  • • Phase3 - 600 participants
  • • This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with arthritis, psoriatic

Where?

  • • Westcliff-on-Sea - Clinical Site
  • • Barnet - Clinical Site
  • • Leeds - Clinical Site
  • • Wolverhampton - Clinical Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

More detail

M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Arthritis, Psoriatic

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PsAtest negative

What the study is looking for

  • ✓Participants must be ≥18 years of age .
  • ✓Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic...
  • ✓Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count...
  • ✓Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
  • ✓Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.

Who cannot take part

  • ✗Participants with a known hypersensitivity to sonelokimab or any of its excipients.
  • ✗Participants with a known hypersensitivity, or any safety concern, to risankizumab or any of its excipients or...
  • ✗Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
  • ✗Participants with a diagnosis of inflammatory bowel disease.
  • ✗Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before...
See the full criteria
Inclusion Criteria: 1. Participants must be ≥18 years of age . 2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit. 3. Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3). 4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO. 5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit. 6. Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor. Exclusion Criteria: 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container. 3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA. 4. Participants with a diagnosis of inflammatory bowel disease. 5. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit. 6. Participants who have an established diagnosis of arthritis mutilans. 7. Previous exposure to sonelokimab. 8. Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα

Where Is This Study? (4 UK sites)

Clinical Site

Westcliff-on-Sea SS0, United Kingdom

Clinical Site

Barnet EN5 3DJ, United Kingdom

Clinical Site

Leeds LS7 4SA, United Kingdom

Clinical Site

Wolverhampton WV10 0QP, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-10