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NCT07223138Enrolling by invitationPhase 3

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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)

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1560 (estimated)
First submitted
20 Oct 2025
Start date
13 Nov 2025
Primary completion date
4 Feb 2028
Lead sponsor
MoonLake Immunotherapeutics AG
NCT number
NCT07223138

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1560
  • From 13 Nov 2025 to the primary completion date, 4 Feb 2028
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who plan to participate in another interventional study for a drug or device during this study.

Other

  • 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

Who the study is looking for

  • 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 visit 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 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.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical Site
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AvondaleUnited StatesUnknown status
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Avon ParkUnited StatesUnknown status
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BaytownUnited StatesUnknown status
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CharlotteUnited StatesUnknown status
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ClearwaterUnited StatesUnknown status
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DuncansvilleUnited StatesUnknown status
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JonesboroUnited StatesUnknown status
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LelandUnited StatesUnknown status
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LubbockUnited StatesUnknown status
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MemphisUnited StatesUnknown status
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MesaUnited StatesUnknown status
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Middleburg HeightsUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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ScottsdaleUnited StatesUnknown status
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TampaUnited StatesUnknown status
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TucsonUnited StatesUnknown status
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UplandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.