A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)
Key facts
- Where
- Budapest, Budapest II, Budapest III, Debrecen, Gyula, Hódmezővásárhely, Kalocsa, Kistarcsa, Nyíregyháza, Székesfehérvár és Veszprem, MagyarországSee the 12 sites
- Phase
- 3. fázis
Where in Magyarország
- Qualiclinic Kft.Budapest, MagyarországToborzás még nem indult
- Betegapolo Irgalmasrend Budai Irgalmasrendi KorhazBudapest II, MagyarországToborzás még nem indult
- Revita Kft.Budapest II, MagyarországToborzás még nem indult
- Obudai Egeszseguegyi Centrum Kft.Budapest III, MagyarországToborzás még nem indult
- University of DebrecenDebrecen, MagyarországToborzás még nem indult
- Bekes Varmegyei Koezponti KorhazGyula, MagyarországToborzás még nem indult
- Vasarhelyi Sarkanyfu Kft.Hódmezővásárhely, MagyarországToborzás még nem indult
- Je-Med Bt.Kalocsa, MagyarországToborzás még nem indult
- Kistarcsai Flor Ferenc KorhazKistarcsa, MagyarországToborzás még nem indult
- Szabolcs Szatmár Bereg Vármegyei OktatókórházNyíregyháza, MagyarországToborzás még nem indult
- Complex Rendelo Med Zrt.Székesfehérvár, MagyarországToborzás még nem indult
- Vital-Medicina Kft.Veszprem, MagyarországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MoonLake Immunotherapeutics AG
- Trial code
- EU 2025-522471-28-00
- Record updated
- 2026. március 9.
- Original description
To evaluate long-term safety and tolerability of sonelokimab in participants with PsARead full original descriptionShow less
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)
To evaluate long-term safety and tolerability of sonelokimab in participants with PsA
Inclusion: Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study; 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; 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; 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; 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; Participants are considered reliable and capable of adhering to the protocol, visit schedule, and medication intake, according to the judgment of the investigator; Participants are able to understand and provide signed informed consent, per local regulations and guidelines.
Exclusion: Participants who plan to participate in another interventional study for a drug or device during this study; Participants who met any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study; Participants who have ongoing or planned use of one or more of the prohibited PsA or non-PsA treatments specified in this protocol; Participants who were unblinded during the parental study; Participant noncompliance to the parental study (significant violation of protocol requirements or any other instances as per investigator’s judgement).