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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
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
