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Trial Title:
Evaluation of Sonelokimab in Patients with Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
NCT ID:
NCT06641089
Condition:
Arthritis, Psoriatic
Conditions: Official terms:
Arthritis
Arthritis, Psoriatic
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Sonelokimab
Description:
Sonelokimab
Arm group label:
sonelokimab dose 1 with an induction regimen
Arm group label:
sonelokimab dose 2 with an induction regimen
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Placebo
Intervention type:
Drug
Intervention name:
Risankizumab
Description:
Active comparator
Arm group label:
risankizumab
Summary:
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.
Detailed description:
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.
Criteria for 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 moderate to severe 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 2 TNFα inhibitors for PsA or PsO and must have
experienced an inadequate response to treatment with the 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.
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 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 15, 2024
Completion date:
January 15, 2027
Lead sponsor:
Agency:
MoonLake Immunotherapeutics AG
Agency class:
Industry
Source:
MoonLake Immunotherapeutics AG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06641089
