Clinical Trials in the USA / NCT07223138
Enrolling by invitation
Phase 3
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis
NCT07223138 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Arthritis, Psoriatic
Study summary
This is a study to demonstrate the long-term safety, tolerability and clinical efficacy of sonelokimab in the treatment of patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302)
Eligibility
Inclusion Criteria:
1. Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study.
2. Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the end-of-treatment visit of the parental study.
3. Participants must have received their last dose of study treatment in the parental study no more than 8 weeks (but ideally 4 weeks) before the first dose in this OLE study.
4. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment.
5. Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.
Exclusion Criteria:
1. Participants who met any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
2. Participants who have ongoing or planned use of one or more of the prohibited PsA or non-PsA treatments specified in this protocol.
3. Participants who plan to participate in another interventional study for a drug or device during this study.
4. Participants who were unblinded during the parental study.
5. Participant noncompliance to the parental study
Primary outcome measure(s)
- Long-term safety and tolerability of sonelokimab: — 52 weeks
Treatment-emergent adverse events (TEAEs) - Long-term safety and tolerability of sonelokimab: — 52 weeks
Serious adverse events (SAEs) - Long-term safety and tolerability of sonelokimab: — 52 weeks
TEAEs leading to study withdrawal - Long-term safety and tolerability of sonelokimab: — 52 weeks
Adverse events of special interest (AESIs) - Long-term safety and tolerability of sonelokimab: — 52 weeks
Clinically significant changes in vital signs and standard 12-lead electrocardiogram Measure description: Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline - Long-term safety and tolerability of sonelokimab: — 52 weeks
Clinically significant changes in clinical laboratory parameters Measure description: Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Site | Avondale | Arizona | |
| Clinical Site | Mesa | Arizona | |
| Clinical Site | Phoenix | Arizona | |
| Clinical Site | Scottsdale | Arizona | |
| Clinical Site | Tucson | Arizona | |
| Clinical Site | Jonesboro | Arkansas | |
| Clinical Site | Upland | California | |
| Clinical Site | Avon Park | Florida | |
| Clinical Site | Clearwater | Florida | |
| Clinical Site | Tampa | Florida | |
| Clinical Site | Charlotte | North Carolina | |
| Clinical Site | Leland | North Carolina | |
| Clinical Site | Middleburg Heights | Ohio | |
| Clinical Site | Duncansville | Pennsylvania | |
| Clinical Site | Memphis | Tennessee | |
| Clinical Site | Baytown | Texas | |
| Clinical Site | Lubbock | Texas |
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Other trials for the same condition
A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis
Active, not recruiting
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Active, not recruiting
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
Active, not recruiting
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07223138 on ClinicalTrials.gov ↗ ← All trials in the USA