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NCT06641076Active, not recruitingPhase 3

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

A Phase 3, Parallel-group, Randomized, Double-blind, 3-arm, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
960 (estimated)
First submitted
11 Oct 2024
Start date
15 Oct 2024
Primary completion date
28 May 2026
Lead sponsor
MoonLake Immunotherapeutics AG
NCT number
NCT06641076

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 960
  • From 15 Oct 2024 to the primary completion date, 28 May 2026
  • 128 sites in 20 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

  • Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
  • Previous exposure to sonelokimab.
  • Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.

Other illness

  • Participants with a known hypersensitivity to sonelokimab or any of its excipients.
  • Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
  • Participants with a diagnosis of inflammatory bowel disease.

Other

  • Participants who have an established diagnosis of arthritis mutilans.

Who the study is looking for

  • Participants must be ≥18 years of age .
  • Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
  • Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
  • Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
  • Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.

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

Full criteria on ClinicalTrials.gov

Sites (128)

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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CalgaryCanadaUnknown status
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Trois-RivièresCanadaUnknown status
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WaterlooCanadaUnknown status
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WinnipegCanadaUnknown status
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BřeclavCzechiaUnknown status
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BrnoCzechiaUnknown status
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OstravaCzechiaUnknown status
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PragueCzechiaUnknown status
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StudénkaCzechiaUnknown status
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ZlínCzechiaUnknown status
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Bad BentheimGermanyUnknown status
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BerlinGermanyUnknown status
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ErlangenGermanyUnknown status
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HamburgGermanyUnknown status
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HerneGermanyUnknown status
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MünchenGermanyUnknown status
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MunichGermanyUnknown status
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TallinnEstoniaUnknown status
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TartuEstoniaUnknown status
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A CoruñaSpainUnknown status
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AlcobendasSpainUnknown status
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BilbaoSpainUnknown status
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CastellóSpainUnknown status
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MadridSpainUnknown status
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MálagaSpainUnknown 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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ValenciaSpainUnknown status
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KuopioFinlandUnknown status
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CahorsFranceUnknown status
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Caluire-et-CuireFranceUnknown status
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ÉchirollesFranceUnknown status
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MontpellierFranceUnknown status
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NarbonneFranceUnknown status
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NiceFranceUnknown status
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RouenFranceUnknown status
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ToursFranceUnknown status
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KutaisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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AthensGreeceUnknown status
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HeraklionGreeceUnknown status
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RijekaCroatiaUnknown status
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ZagrebCroatiaUnknown status
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BudapestHungaryUnknown status
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DebrecenHungaryUnknown status
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GyulaHungaryUnknown status
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HódmezővásárhelyHungaryUnknown status
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KalocsaHungaryUnknown status
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KistarcsaHungaryUnknown status
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NyíregyházaHungaryUnknown status
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VeszprémHungaryUnknown status
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KaunasLithuaniaUnknown status
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KlaipėdaLithuaniaUnknown status
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ŠiauliaiLithuaniaUnknown status
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VilniusLithuaniaUnknown status
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AdaziLatviaUnknown status
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RigaLatviaUnknown status
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BialystokPolandUnknown status
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BydgoszczPolandUnknown status
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BytomPolandUnknown status
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CzęstochowaPolandUnknown status
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DąbrówkaPolandUnknown status
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DębicaPolandUnknown status
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ElblagPolandUnknown status
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GdyniaPolandUnknown status
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LodzPolandUnknown status
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LublinPolandUnknown status
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Nowa SólPolandUnknown status
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PoznanPolandUnknown status
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SiedlcePolandUnknown status
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TorunPolandUnknown status
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WołominPolandUnknown status
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WroclawPolandUnknown status
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ZamośćPolandUnknown status
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BragaPortugalUnknown status
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LisbonPortugalUnknown status
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Ponte de LimaPortugalUnknown status
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BucharestRomaniaUnknown status
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TimișoaraRomaniaUnknown status
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BelgradeSerbiaUnknown status
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Niška BanjaSerbiaUnknown status
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Novi SadSerbiaUnknown status
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KošiceSlovakiaUnknown status
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MartinSlovakiaUnknown status
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PopradSlovakiaUnknown status
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Rimavská SobotaSlovakiaUnknown status
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AllenUnited StatesUnknown status
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AvondaleUnited StatesUnknown status
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Avon ParkUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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BeckleyUnited StatesUnknown status
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ChandlerUnited StatesUnknown status
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ClearwaterUnited StatesUnknown status
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ColleyvilleUnited StatesUnknown status
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FlagstaffUnited StatesUnknown status
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Grand BlancUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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Lake CharlesUnited 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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PlanoUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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SalisburyUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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ScottsdaleUnited StatesUnknown status
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SpringfieldUnited StatesUnknown status
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StatesvilleUnited 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.