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New drug sonelokimab aims to ease psoriatic arthritis pain

NCT ID NCT06641076

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Updated 4 times

Summary

This study tests a drug called sonelokimab in 960 adults with active psoriatic arthritis who have not used biologic treatments before. The goal is to see if it reduces joint pain and swelling better than a placebo. Participants receive injections over several months, and researchers track improvements in joint symptoms and skin psoriasis.

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 it works, this could offer a new treatment option for people with psoriatic arthritis who haven't tried biologic drugs before.
What could go wrong
This is a late-stage trial, but results are not yet available. The drug may not work better than placebo, and side effects like infections are possible.

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 960 people

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

Started

Oct 2024

Expected to finish

Feb 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. Exclusion Criteria: 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA. 3. Participants with a diagnosis of inflammatory bowel disease. 4. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit. 5. Participants who have an established diagnosis of arthritis mutilans. 6. Previous exposure to sonelokimab. 7. Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.

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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

Contacts and locations

Locations

  • Clinical SIte

    Budapest, 1023, Hungary

  • Clinical SIte

    Braga, 4700-000, Portugal

  • Clinical Site

    Avondale, Arizona, 85392, United States

  • Clinical Site

    Chandler, Arizona, 85225, United States

  • Clinical Site

    Flagstaff, Arizona, 86001, United States

  • Clinical Site

    Mesa, Arizona, 85210, United States

  • Clinical Site

    Phoenix, Arizona, 85032, United States

  • Clinical Site

    Scottsdale, Arizona, 85260, United States

  • Clinical Site

    Tucson, Arizona, 85748, United States

  • Clinical Site

    San Diego, California, 92108, United States

  • Clinical Site

    Upland, California, 91786, United States

  • Clinical Site

    Avon Park, Florida, 33825, United States

  • Clinical Site

    Clearwater, Florida, 33765, United States

  • Clinical Site

    Hialeah, Florida, 33016, United States

  • Clinical Site

    Tampa, Florida, 33607, United States

  • Clinical Site

    Springfield, Illinois, 62702, United States

  • Clinical Site

    Lake Charles, Louisiana, 70605, United States

  • Clinical Site

    Baltimore, Maryland, 21224-6821, United States

  • Clinical Site

    Grand Blanc, Michigan, 48439-2451, United States

  • Clinical Site

    Leland, North Carolina, 28451, United States

  • Clinical Site

    Salisbury, North Carolina, 28144, United States

  • Clinical Site

    Statesville, North Carolina, 28625, United States

  • Clinical Site

    Middleburg Heights, Ohio, 44130, United States

  • Clinical Site

    Portland, Oregon, 97239, United States

  • Clinical Site

    Memphis, Tennessee, 38119, United States

  • Clinical Site

    Allen, Texas, 75013, United States

  • Clinical Site

    Colleyville, Texas, 76034, United States

  • Clinical Site

    Lubbock, Texas, 79424, United States

  • Clinical Site

    Plano, Texas, 75024, United States

  • Clinical Site

    Beckley, West Virginia, 25801, United States

  • Clinical Site

    Pleven, 5800, Bulgaria

  • Clinical Site

    Plovdiv, 4000, Bulgaria

  • Clinical Site

    Plovdiv, 4001, Bulgaria

  • Clinical Site

    Plovdiv, 4002, Bulgaria

  • Clinical Site

    Plovdiv, 4004, Bulgaria

  • Clinical Site

    Rousse, 7000, Bulgaria

  • Clinical Site

    Sofia, 1463, Bulgaria

  • Clinical Site

    Sofia, 1606, Bulgaria

  • Clinical Site

    Sofia, 1784, Bulgaria

  • Clinical Site

    Stara Zagora, 6003, Bulgaria

  • Clinical Site

    Calgary, T2N 4L7, Canada

  • Clinical Site

    Trois-Rivières, G9A 3X2, Canada

  • Clinical Site

    Waterloo, N2J 1C4, Canada

  • Clinical Site

    Winnipeg, R3A IM3, Canada

  • Clinical Site

    Rijeka, 51 000, Croatia

  • Clinical Site

    Zagreb, 10000, Croatia

  • Clinical Site

    Brno, 63800, Czechia

  • Clinical Site

    Břeclav, 690 02, Czechia

  • Clinical Site

    Ostrava, 70200, Czechia

  • Clinical Site

    Prague, 12850, Czechia

  • Clinical Site

    Prague, 140 00, Czechia

  • Clinical Site

    Prague, 140 59, Czechia

  • Clinical Site

    Prague, 14800, Czechia

  • Clinical Site

    Prague, 150 00, Czechia

  • Clinical Site

    Studénka, 742 13, Czechia

  • Clinical Site

    Zlín, 760 01, Czechia

  • Clinical Site

    Tallinn, 10117, Estonia

  • Clinical Site

    Tallinn, 13419, Estonia

  • Clinical Site

    Tartu, 50708, Estonia

  • Clinical Site

    Kuopio, 70100, Finland

  • Clinical Site

    Cahors, 46000, France

  • Clinical Site

    Caluire-et-Cuire, 69300, France

  • Clinical Site

    Échirolles, 38700, France

  • Clinical Site

    Montpellier, 34295, France

  • Clinical Site

    Narbonne, 11100, France

  • Clinical Site

    Nice, 06001, France

  • Clinical Site

    Rouen, 76031, France

  • Clinical Site

    Tours, 37170, France

  • Clinical Site

    Kutaisi, 4600, Georgia

  • Clinical Site

    Tbilisi, 0102, Georgia

  • Clinical Site

    Tbilisi, 0112, Georgia

  • Clinical Site

    Tbilisi, 0141, Georgia

  • Clinical Site

    Tbilisi, 0159, Georgia

  • Clinical Site

    Tbilisi, 0160, Georgia

  • Clinical Site

    Tbilisi, 0179, Georgia

  • Clinical Site

    Tbilisi, 0180, Georgia

  • Clinical Site

    Tbilisi, Georgia

  • Clinical Site

    Bad Bentheim, 48455, Germany

  • Clinical Site

    Berlin, 12161, Germany

  • Clinical Site

    Berlin, 12203, Germany

  • Clinical Site

    Berlin, 13125, Germany

  • Clinical Site

    Erlangen, 91054, Germany

  • Clinical Site

    Hamburg, 20095, Germany

  • Clinical Site

    Herne, 44649, Germany

  • Clinical Site

    Munich, 80639, Germany

  • Clinical Site

    Munich, 81667, Germany

  • Clinical Site

    München, 80336, Germany

  • Clinical Site

    Athens, Attica, 11521, Greece

  • Clinical Site

    Athens, 12462, Greece

  • Clinical Site

    Heraklion, 71110, Greece

  • Clinical Site

    Budapest, 1027, Hungary

  • Clinical Site

    Budapest, 1036, Hungary

  • Clinical Site

    Debrecen, H-4032, Hungary

  • Clinical Site

    Gyula, 5700, Hungary

  • Clinical Site

    Hódmezővásárhely, 6800, Hungary

  • Clinical Site

    Kalocsa, 6300, Hungary

  • Clinical Site

    Kistarcsa, 2143, Hungary

  • Clinical Site

    Nyíregyháza, 4400, Hungary

  • Clinical Site

    Székesfehérvár, 8000, Hungary

  • Clinical Site

    Veszprém, 8200, Hungary

  • Clinical Site

    Adazi, LV2164, Latvia

  • Clinical Site

    Riga, LV-1001, Latvia

  • Clinical Site

    Kaunas, 51270, Lithuania

  • Clinical Site

    Klaipėda, LT-92288, Lithuania

  • Clinical Site

    Šiauliai, 76231, Lithuania

  • Clinical Site

    Vilnius, 01117, Lithuania

  • Clinical Site

    Bialystok, 15-879, Poland

  • Clinical Site

    Bialystok, 15707, Poland

  • Clinical Site

    Bydgoszcz, 85-065, Poland

  • Clinical Site

    Bydgoszcz, 85-168, Poland

  • Clinical Site

    Bytom, 41-902, Poland

  • Clinical Site

    Częstochowa, 42-202, Poland

  • Clinical Site

    Dąbrówka, 62-069, Poland

  • Clinical Site

    Dębica, 39-200, Poland

  • Clinical Site

    Elblag, 82-300, Poland

  • Clinical Site

    Gdynia, 81-384, Poland

  • Clinical Site

    Katowice, 40282, Poland

  • Clinical Site

    Krakow, 30-002, Poland

  • Clinical Site

    Krakow, 30-149, Poland

  • Clinical Site

    Krakow, 31-501, Poland

  • Clinical Site

    Lodz, 90-368, Poland

  • Clinical Site

    Lodz, 91-363, Poland

  • Clinical Site

    Lublin, 20-412, Poland

  • Clinical Site

    Lublin, 20-607, Poland

  • Clinical Site

    Nadarzyn, 05-830, Poland

  • Clinical Site

    Nowa Sól, 67-100, Poland

  • Clinical Site

    Olsztyn, 10-117, Poland

  • Clinical Site

    Poznan, 60-218, Poland

  • Clinical Site

    Poznan, 60-324, Poland

  • Clinical Site

    Poznan, 60-446, Poland

  • Clinical Site

    Poznan, 60-681, Poland

  • Clinical Site

    Poznan, 60-693, Poland

  • Clinical Site

    Poznan, 61-113, Poland

  • Clinical Site

    Poznan, 61-397, Poland

  • Clinical Site

    Siedlce, 08-110, Poland

  • Clinical Site

    Sochaczew, 96-500, Poland

  • Clinical Site

    Swidnica, 58100, Poland

  • Clinical Site

    Torun, 87-100, Poland

  • Clinical Site

    Warsaw, 00-874, Poland

  • Clinical Site

    Warsaw, 01-691, Poland

  • Clinical Site

    Warsaw, 02-118, Poland

  • Clinical Site

    Warsaw, 02-665, Poland

  • Clinical Site

    Warsaw, 02-677, Poland

  • Clinical Site

    Warsaw, 03-291, Poland

  • Clinical Site

    Warsaw, 04-305, Poland

  • Clinical Site

    Wołomin, 05-200, Poland

  • Clinical Site

    Wroclaw, 51-685, Poland

  • Clinical Site

    Wroclaw, 52-416, Poland

  • Clinical Site

    Wroclaw, 53-673, Poland

  • Clinical Site

    Zamość, 22400, Poland

  • Clinical Site

    Braga, 4710-243, Portugal

  • Clinical Site

    Lisbon, 1500-458, Portugal

  • Clinical Site

    Lisbon, 1649-035, Portugal

  • Clinical Site

    Ponte de Lima, 4990-041, Portugal

  • Clinical Site

    Bucharest, 011172, Romania

  • Clinical Site

    Bucharest, 012071, Romania

  • Clinical Site

    Bucharest, 020475, Romania

  • Clinical Site

    Bucharest, 030463, Romania

  • Clinical Site

    Bucharest, 041303, Romania

  • Clinical Site

    Timișoara, 300650, Romania

  • Clinical Site

    Belgrade, 11000, Serbia

  • Clinical Site

    Niška Banja, 18205, Serbia

  • Clinical Site

    Novi Sad, 21000, Serbia

  • Clinical Site

    Košice, 04011, Slovakia

  • Clinical Site

    Martin, 036 01, Slovakia

  • Clinical Site

    Poprad, 058 01, Slovakia

  • Clinical Site

    Rimavská Sobota, 979 01, Slovakia

  • Clinical Site

    A Coruña, 15006, Spain

  • Clinical Site

    Alcobendas, 28100, Spain

  • Clinical Site

    Bilbao, 48013, Spain

  • Clinical Site

    Castelló, 12004, Spain

  • Clinical Site

    Madrid, 28003, Spain

  • Clinical Site

    Madrid, 28046, Spain

  • Clinical Site

    Málaga, 29009, Spain

  • Clinical Site

    Sabadell, 08208, Spain

  • Clinical Site

    Santiago de Compostela, 15702, Spain

  • Clinical Site

    Santiago de Compostela, 15706, Spain

  • Clinical Site

    Seville, 41007, Spain

  • Clinical Site

    Seville, 41009, Spain

  • Clinical Site

    Seville, 41010, Spain

  • Clinical Site

    Seville, 41013, Spain

  • Clinical Site

    Valencia, 46007, Spain

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