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Long-term safety of sonelokimab injections in people with psoriatic arthritis

Tests sonelokimab injections, given under the skin, in adults with psoriatic arthritis.

Key facts

Who runs it
MoonLake Immunotherapeutics AG
Where
Athens, Chaïdári, and Heraklion, GreeceSee the 3 sitesAlso in 15 other countries, 144 sites
Registry title
A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)
Status
Not yet recruiting
Phase
Phase 3
People taking part
948 people, planned
Started
1 Mar 2026
Expected to end
4 Feb 2028
Type of study
Interventional
Record updated
9 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with psoriatic arthritis who finished the 52-week parent study and took part in it with sonelokimab treatment.

Age
18 years or older
Sex
All sexes can join
Disease stage
Psoriatic arthritis; must have completed the end-of-treatment visit (Week 52) of the parent study
Earlier treatment
Must have taken the last dose in the parent study no more than 8 weeks (ideally 4 weeks) before the first dose in this study

Main reasons for not taking part

  • Met a reason to stop treatment in the parent study at the time of joining
  • Uses or plans to use treatments that are not allowed in this study
  • Plans to join another study of a drug or device during this study
  • Was unblinded during the parent study
  • Did not follow the rules of the parent study

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Greece

Also in 15 other countries, 144 sites

  • Athens Naval HospitalAthens, GreeceNot yet recruiting
  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"Chaïdári, GreeceNot yet recruiting
  • University General Hospital of HeraklionHeraklion, GreeceNot yet recruiting

About the trial

What the trial wants to find out

To evaluate long-term safety and tolerability of sonelokimab in participants with PsA

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Long-term safety of sonelokimab injections in people with psoriatic arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
9 March 2026