Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
MoonLake Immunotherapeutics AG · Industry
Who this trial is looking for
This trial is looking for adults with active psoriatic arthritis who did not respond well to past treatments. Participants will take sonelokimab or a placebo to see how well it works and if it is safe.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with psoriatic arthritis for at least 6 months.
I have active psoriatic arthritis with at least 3 tender and 3 swollen joints.
I currently have plaque psoriasis or a history of it confirmed by a dermatologist.
I have tested negative for rheumatoid factor and anti-cyclic citrullinated peptide.
I have received at least one TNFα inhibitor and did not respond well or stopped due to side effects.
You may not be able to join if
I am allergic to sonelokimab or its ingredients.
I have an allergy to risankizumab or its components.
I have other chronic inflammatory conditions besides psoriasis or psoriatic arthritis.
I have inflammatory bowel disease.
I have had unexplained diarrhea for 3 weeks or more in the last 24 weeks.
I have been diagnosed with arthritis mutilans.
I have used sonelokimab before.
I have ever taken biologic treatments for psoriasis or psoriatic arthritis that do not target TNFα.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility 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 (d…
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
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