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New hope for psoriatic arthritis sufferers: experimental drug sonelokimab enters final testing phase

NCT ID NCT06641089

Disease control Sponsor: MoonLake Immunotherapeutics AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study tests a new drug called sonelokimab for adults with active psoriatic arthritis who have not improved with or cannot take standard TNF-blocker medications. About 600 participants will receive either sonelokimab, a placebo, or an existing drug (risankizumab) for comparison. The main goal is to see if sonelokimab reduces joint pain and swelling by at least 50%.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sonelokimab
What this could lead to
If successful, sonelokimab could offer a new treatment option for people with psoriatic arthritis who have not responded to or cannot tolerate current TNF-blocker therapies.
What could go wrong
This is a Phase 3 trial, but it is still experimental. The drug may not prove more effective than existing treatments, and side effects are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants must be ≥18 years of age . 2. 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. 3. Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3). 4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO. 5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit. 6. Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor. Exclusion Criteria: 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container. 3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA. 4. Participants with a diagnosis of inflammatory bowel disease. 5. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit. 6. Participants who have an established diagnosis of arthritis mutilans. 7. Previous exposure to sonelokimab. 8. Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα

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Conditions

The condition(s) this trial relates to.

psoriatic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis, psoriatic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    124 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical SIte

    RECRUITING

    Gyula, 5700, Hungary

  • Clinical SIte

    RECRUITING

    Sabadell, 08208, Spain

  • Clinical Site

    RECRUITING

    Avondale, Arizona, 85392, United States

  • Clinical Site

    COMPLETED

    Chandler, Arizona, 85225, United States

  • Clinical Site

    COMPLETED

    Flagstaff, Arizona, 86001, United States

  • Clinical Site

    RECRUITING

    Mesa, Arizona, 85210, United States

  • Clinical Site

    RECRUITING

    Phoenix, Arizona, 85032, United States

  • Clinical Site

    RECRUITING

    Scottsdale, Arizona, 85260, United States

  • Clinical Site

    RECRUITING

    Tucson, Arizona, 85748, United States

  • Clinical Site

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Clinical Site

    RECRUITING

    La Jolla, California, 92037, United States

  • Clinical Site

    RECRUITING

    Pomona, California, 91767, United States

  • Clinical Site

    COMPLETED

    San Diego, California, 92108, United States

  • Clinical Site

    RECRUITING

    Santa Monica, California, 90404, United States

  • Clinical Site

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • Clinical Site

    RECRUITING

    Upland, California, 91786, United States

  • Clinical Site

    RECRUITING

    Avon Park, Florida, 33825, United States

  • Clinical Site

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Clinical Site

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Clinical Site

    RECRUITING

    Miami Gardens, Florida, 33014, United States

  • Clinical Site

    RECRUITING

    Tampa, Florida, 33607, United States

  • Clinical Site

    RECRUITING

    Zephyrhills, Florida, 33542, United States

  • Clinical Site

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Clinical Site

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Clinical Site

    RECRUITING

    Lake Charles, Louisiana, 70605, United States

  • Clinical Site

    RECRUITING

    Baltimore, Maryland, 21224-6821, United States

  • Clinical Site

    COMPLETED

    Grand Blanc, Michigan, 48439-2451, United States

  • Clinical Site

    RECRUITING

    Brooklyn, New York, 11201, United States

  • Clinical Site

    RECRUITING

    Rochester, New York, 14642, United States

  • Clinical Site

    RECRUITING

    Charlotte, North Carolina, 28262, United States

  • Clinical Site

    RECRUITING

    Leland, North Carolina, 28451, United States

  • Clinical Site

    RECRUITING

    Middleburg Heights, Ohio, 44130, United States

  • Clinical Site

    RECRUITING

    Portland, Oregon, 97239, United States

  • Clinical Site

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Clinical Site

    RECRUITING

    Jackson, Tennessee, 38305, United States

  • Clinical Site

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Clinical Site

    COMPLETED

    Murfreesboro, Tennessee, 37128, United States

  • Clinical Site

    COMPLETED

    Allen, Texas, 75013, United States

  • Clinical Site

    RECRUITING

    Austin, Texas, 78745, United States

  • Clinical Site

    RECRUITING

    Baytown, Texas, 77521, United States

  • Clinical Site

    RECRUITING

    Colleyville, Texas, 76034, United States

  • Clinical Site

    COMPLETED

    Houston, Texas, 77089, United States

  • Clinical Site

    RECRUITING

    Lubbock, Texas, 79424, United States

  • Clinical Site

    COMPLETED

    Plano, Texas, 75024, United States

  • Clinical Site

    RECRUITING

    Seattle, Washington, 98122, United States

  • Clinical Site

    RECRUITING

    Beckley, West Virginia, 25801, United States

  • Clinical Site

    RECRUITING

    Pazardzhik, 4400, Bulgaria

  • Clinical Site

    RECRUITING

    Pleven, 5800, Bulgaria

  • Clinical Site

    RECRUITING

    Plovdiv, 4000, Bulgaria

  • Clinical Site

    RECRUITING

    Plovdiv, 4001, Bulgaria

  • Clinical Site

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Clinical Site

    RECRUITING

    Plovdiv, 4003, Bulgaria

  • Clinical Site

    RECRUITING

    Plovdiv, 4004, Bulgaria

  • Clinical Site

    RECRUITING

    Rousse, 7000, Bulgaria

  • Clinical Site

    RECRUITING

    Sofia, 1462, Bulgaria

  • Clinical Site

    RECRUITING

    Sofia, 1606, Bulgaria

  • Clinical Site

    COMPLETED

    Sofia, 1784, Bulgaria

  • Clinical Site

    RECRUITING

    Stara Zagora, 6003, Bulgaria

  • Clinical Site

    RECRUITING

    Toronto, Ontario, M5S1B2, Canada

  • Clinical Site

    RECRUITING

    Calgary, T2N 4L7, Canada

  • Clinical Site

    RECRUITING

    Trois-Rivières, G9A 3X2, Canada

  • Clinical Site

    COMPLETED

    Waterloo, N2J 1C4, Canada

  • Clinical Site

    RECRUITING

    Winnipeg, R3A IM3, Canada

  • Clinical Site

    RECRUITING

    Brno, 63800, Czechia

  • Clinical Site

    RECRUITING

    Ostrava, 70200, Czechia

  • Clinical Site

    COMPLETED

    Studénka, 742 13, Czechia

  • Clinical Site

    RECRUITING

    Zlín, 760 01, Czechia

  • Clinical Site

    COMPLETED

    Caluire-et-Cuire, 69300, France

  • Clinical Site

    RECRUITING

    Montpellier, 34295, France

  • Clinical Site

    COMPLETED

    Narbonne, 11100, France

  • Clinical Site

    RECRUITING

    Nice, 06001, France

  • Clinical Site

    COMPLETED

    Rouen, 76031, France

  • Clinical Site

    RECRUITING

    Tours, 37170, France

  • Clinical Site

    RECRUITING

    Tbilisi, 0102, Georgia

  • Clinical Site

    RECRUITING

    Tbilisi, 0112, Georgia

  • Clinical Site

    RECRUITING

    Tbilisi, 0141, Georgia

  • Clinical Site

    RECRUITING

    Tbilisi, 0159, Georgia

  • Clinical Site

    RECRUITING

    Tbilisi, 0179, Georgia

  • Clinical Site

    RECRUITING

    Tbilisi, 0180, Georgia

  • Clinical Site

    RECRUITING

    Tbilisi, 0186, Georgia

  • Clinical Site

    RECRUITING

    Tbilisi, Georgia

  • Clinical Site

    COMPLETED

    Berlin, 12161, Germany

  • Clinical Site

    RECRUITING

    Berlin, 12203, Germany

  • Clinical Site

    RECRUITING

    Berlin, 13125, Germany

  • Clinical Site

    RECRUITING

    Dresden, 01067, Germany

  • Clinical Site

    RECRUITING

    Erlangen, 91054, Germany

  • Clinical Site

    RECRUITING

    Frankfurt, 60528, Germany

  • Clinical Site

    RECRUITING

    Hamburg, 20095, Germany

  • Clinical Site

    RECRUITING

    Herne, 44649, Germany

  • Clinical Site

    RECRUITING

    Munich, 80639, Germany

  • Clinical Site

    RECRUITING

    Munich, 81667, Germany

  • Clinical Site

    RECRUITING

    München, 80336, Germany

  • Clinical Site

    RECRUITING

    Budapest, 1027, Hungary

  • Clinical Site

    COMPLETED

    Budapest, 1036, Hungary

  • Clinical Site

    COMPLETED

    Debrecen, H-4032, Hungary

  • Clinical Site

    RECRUITING

    Hódmezővásárhely, 6800, Hungary

  • Clinical Site

    RECRUITING

    Nyíregyháza, 4400, Hungary

  • Clinical Site

    RECRUITING

    Székesfehérvár, 8000, Hungary

  • Clinical Site

    RECRUITING

    Szolnok, 5000, Hungary

  • Clinical Site

    RECRUITING

    Veszprém, 8200, Hungary

  • Clinical Site

    RECRUITING

    Bialystok, 15707, Poland

  • Clinical Site

    RECRUITING

    Bydgoszcz, 85-065, Poland

  • Clinical Site

    COMPLETED

    Częstochowa, 42-202, Poland

  • Clinical Site

    RECRUITING

    Elblag, 82-300, Poland

  • Clinical Site

    RECRUITING

    Gdynia, 81-384, Poland

  • Clinical Site

    RECRUITING

    Krakow, 30-002, Poland

  • Clinical Site

    RECRUITING

    Krakow, 30-149, Poland

  • Clinical Site

    RECRUITING

    Krakow, 31-501, Poland

  • Clinical Site

    RECRUITING

    Lodz, 91-363, Poland

  • Clinical Site

    RECRUITING

    Nadarzyn, 05-830, Poland

  • Clinical Site

    RECRUITING

    Poznan, 60-324, Poland

  • Clinical Site

    RECRUITING

    Poznan, 60-446, Poland

  • Clinical Site

    RECRUITING

    Poznan, 60-693, Poland

  • Clinical Site

    RECRUITING

    Poznan, 61-397, Poland

  • Clinical Site

    RECRUITING

    Sochaczew, 96-500, Poland

  • Clinical Site

    RECRUITING

    Swidnica, 58100, Poland

  • Clinical Site

    RECRUITING

    Warsaw, 00-874, Poland

  • Clinical Site

    RECRUITING

    Warsaw, 02-118, Poland

  • Clinical Site

    RECRUITING

    Warsaw, 02-665, Poland

  • Clinical Site

    RECRUITING

    Warsaw, 02-677, Poland

  • Clinical Site

    RECRUITING

    Warsaw, 02-786, Poland

  • Clinical Site

    RECRUITING

    Warsaw, 03-291, Poland

  • Clinical Site

    RECRUITING

    Warsaw, 04-305, Poland

  • Clinical Site

    RECRUITING

    Wołomin, 05-200, Poland

  • Clinical Site

    RECRUITING

    Wroclaw, 51-685, Poland

  • Clinical Site

    RECRUITING

    Wroclaw, 53-673, Poland

  • Clinical Site

    RECRUITING

    A Coruña, 15006, Spain

  • Clinical Site

    RECRUITING

    Alcobendas, 28100, Spain

  • Clinical Site

    RECRUITING

    Bilbao, 48013, Spain

  • Clinical Site

    RECRUITING

    Castellon, 12004, Spain

  • Clinical Site

    RECRUITING

    Madrid, 28003, Spain

  • Clinical Site

    RECRUITING

    Málaga, 29009, Spain

  • Clinical Site

    RECRUITING

    Santiago de Compostela, 15702, Spain

  • Clinical Site

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Clinical Site

    COMPLETED

    Seville, 41009, Spain

  • Clinical Site

    RECRUITING

    Seville, 41010, Spain

  • Clinical Site

    RECRUITING

    Seville, 41013, Spain

  • Clinical Site

    RECRUITING

    Valencia, 46010, Spain

  • Clinical Site

    RECRUITING

    Westcliff-on-Sea, Essex, SS0, United Kingdom

  • Clinical Site

    RECRUITING

    Barnet, EN5 3DJ, United Kingdom

  • Clinical Site

    RECRUITING

    Leeds, LS7 4SA, United Kingdom

  • Clinical Site

    RECRUITING

    Wolverhampton, WV10 0QP, United Kingdom

  • Clinical site

    RECRUITING

    Katowice, 40-282, Poland

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