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New treatment option for Arthritis, Psoriatic
Official title Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
ClinicalTrials.gov ID: NCT06641089
What this study is testing
What is Sonelokimab?
Sonelokimab is an investigational medicine, being studied as a potential treatment for arthritis, psoriatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must be ≥18 years of age .
- Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with...
- Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).
- 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.
You likely can't join if
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
- 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 the Baseline Visit.
- Participants who have an established diagnosis of arthritis mutilans.
See the full eligibility criteria
- Participants must be ≥18 years of age .
- 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.
- Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).
- 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.
- 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...
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
- 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 the Baseline Visit.
- Participants who have an established diagnosis of arthritis mutilans.
- Previous exposure to sonelokimab.
- Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα
The study team makes the final eligibility decision.
Where it's taking place
- Avondale, Arizona, United States
- Chandler, Arizona, United States
- Flagstaff, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Jonesboro, Arkansas, United States
- La Jolla, California, United States
- Pomona, California, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Thousand Oaks, California, United States
- Upland, California, United States
- Avon Park, Florida, United States
- Clearwater, Florida, United States
- Hialeah, Florida, United States
- Miami Gardens, Florida, United States
- Tampa, Florida, United States
- Zephyrhills, Florida, United States
+ 88 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avondale, Arizona, United States; Chandler, Arizona, United States; Flagstaff, Arizona, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States and 102 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.