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NCT05640245CompletedPhase 2

Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
207 (actual)
First submitted
28 Nov 2022
Start date
Dec 2022
Primary completion date
Sept 2023
Lead sponsor
MoonLake Immunotherapeutics AG
NCT number
NCT05640245

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 207
  • From Dec 2022 to the primary completion date, Sept 2023
  • 35 sites in 8 countries
  • 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

  • Participant who has previously failed on anti-interleukin (IL)-17 therapy;
  • Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy;
  • Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit;

Other illness

  • Participant with known hypersensitivity to sonelokimab or any of its excipients;
  • Participant with known hypersensitivity to adalimumab or any of its excipients;
  • Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA;

Other

  • Participant who has a diagnosis of arthritis mutilans

Who the study is looking for

  • Participant is ≥18 years of age;
  • Participant has a confirmed diagnosis of PsA per the 2006 Classification criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit;
  • Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3);
  • Participant has either current active PsO or a dermatologist confirmed history of PsO;
  • Participant tests negative for rheumatoid factor (RF) at the Screening Visit;
  • Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit;
  • Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information.

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

Full criteria on ClinicalTrials.gov

Sites (35)

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

SiteCityCountrySite status
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PlevenBulgariaUnknown status
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PlovdivBulgariaUnknown status
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RousseBulgariaUnknown status
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SofiaBulgariaUnknown status
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Stara ZagoraBulgariaUnknown status
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VarnaBulgariaUnknown status
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OstravaCzechiaUnknown status
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HamburgGermanyUnknown status
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HerneGermanyUnknown status
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TallinnEstoniaUnknown status
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TartuEstoniaUnknown status
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MadridSpainUnknown status
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SabadellSpainUnknown status
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Santiago de CompostelaSpainUnknown status
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SevilleSpainUnknown status
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BudapestHungaryUnknown status
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SzékesfehérvárHungaryUnknown status
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SzentesHungaryUnknown status
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VeszprémHungaryUnknown status
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BialystokPolandUnknown status
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BydgoszczPolandUnknown status
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ElblagPolandUnknown status
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GdyniaPolandUnknown status
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KrakowPolandUnknown status
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LodzPolandUnknown status
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NadarzynPolandUnknown status
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Nowa SólPolandUnknown status
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OlsztynPolandUnknown status
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PoznanPolandUnknown status
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SochaczewPolandUnknown status
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SwidnicaPolandUnknown status
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WarsawPolandUnknown status
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WroclawPolandUnknown status
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DuncansvilleUnited StatesUnknown status
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Rancho MirageUnited StatesUnknown status

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