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A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)
EU CTIS ID: 2025-522471-28-00
What this study is testing
To evaluate long-term safety and tolerability of sonelokimab in participants with PsA
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (EOT) visit (Week 52) 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 (WONCBP) or (if childbearing potential [WOCBP]) 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. WOCBP must have a negative urine pregnancy test in the week prior to the first administration of treatment in this OLE study (Week 0). 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. NOTE: These precautions for contraception in WOCBP are required for 21 weeks after the last dose of study treatment in the parental study M1095-PsA-302, in case of study drug discontinuations occurring during the first 9 weeks of OLE. Additional precautions in WOCBP may also be required due to the use of any other concomitant medications.
- 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.
- 6. Participants are considered reliable and capable of adhering to the protocol, visit schedule, and medication intake, according to the judgment of the investigator.
You likely can't join if
- 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 (significant violation of protocol requirements or any other instances as per investigator’s judgement).
See the full eligibility criteria
Who can join
- 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 (EOT) visit (Week 52) 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 (WONCBP) or (if childbearing potential [WOCBP]) 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. WOCBP must have a negative urine pregnancy test in the week prior to the first administration of treatment in this OLE study (Week 0). 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. NOTE: These precautions for contraception in WOCBP are required for 21 weeks after the last dose of study treatment in the parental study M1095-PsA-302, in case of study drug discontinuations occurring during the first 9 weeks of OLE. Additional precautions in WOCBP may also be required due to the use of any other concomitant medications.
- 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.
- 6. Participants are considered reliable and capable of adhering to the protocol, visit schedule, and medication intake, according to the judgment of the investigator.
- 7. Participants are able to understand and provide signed informed consent, per local regulations and guidelines.
What rules you out
- 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 (significant violation of protocol requirements or any other instances as per investigator’s judgement).
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Chile
- United Kingdom
- Mexico
- Canada
- Georgia
- United States
- Serbia
- Colombia
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Chile; United Kingdom; Mexico; Canada; Georgia and 3 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 EU CTIS; the study team decides eligibility.