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Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active psoriatic arthritis

NCT ID NCT05640245

NEW 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 10, 2026

Summary

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.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

207 people

The number who actually took part.

Started

Dec 2022

Finished

Jan 2024

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. Participant is ≥18 years of age; 2. 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; 3. Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3); 4. Participant has either current active PsO or a dermatologist confirmed history of PsO; 5. Participant tests negative for rheumatoid factor (RF) at the Screening Visit; 6. Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit; 7. Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information. Exclusion Criteria: 1. Participant with known hypersensitivity to sonelokimab or any of its excipients; 2. Participant with known hypersensitivity to adalimumab or any of its excipients; 3. Participant who has previously failed on anti-interleukin (IL)-17 therapy; 4. Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy; 5. Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit; 6. Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA; 7. Participant who has a diagnosis of arthritis mutilans

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Conditions

The condition(s) this trial relates to.

arthritic joint disease arthropathy psoriasis psoriatic arthritis skin disorder

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

    Wroclaw, 52-416, Poland

  • Clinical Site

    Rancho Mirage, California, 92260, United States

  • Clinical Site

    Duncansville, Pennsylvania, 16635, United States

  • Clinical Site

    Pleven, 5800, Bulgaria

  • Clinical Site

    Pleven, 5803, Bulgaria

  • Clinical Site

    Plovdiv, 4002, Bulgaria

  • Clinical Site

    Plovdiv, 4003, Bulgaria

  • Clinical Site

    Rousse, 7002, Bulgaria

  • Clinical Site

    Sofia, 1336, Bulgaria

  • Clinical Site

    Stara Zagora, 6000, Bulgaria

  • Clinical Site

    Varna, 9000, Bulgaria

  • Clinical Site

    Ostrava, 702 00, Czechia

  • Clinical Site

    Tallinn, 10128, Estonia

  • Clinical Site

    Tartu, 20708, Estonia

  • Clinical Site

    Hamburg, 20095, Germany

  • Clinical Site

    Herne, 44649, Germany

  • Clinical Site

    Budapest, 1023, Hungary

  • Clinical Site

    Budapest, 1027, Hungary

  • Clinical Site

    Budapest, 1036, Hungary

  • Clinical Site

    Szentes, 6600, Hungary

  • Clinical Site

    Székesfehérvár, 8000, Hungary

  • Clinical Site

    Veszprém, 8200, Hungary

  • Clinical Site

    Bialystok, 15-077, Poland

  • Clinical Site

    Bialystok, 15-351, Poland

  • Clinical Site

    Bialystok, 15-879, Poland

  • Clinical Site

    Bydgoszcz, 85-065, Poland

  • Clinical Site

    Bydgoszcz, 85-168, Poland

  • Clinical Site

    Elblag, 82-300, Poland

  • Clinical Site

    Gdynia, 81-338, Poland

  • Clinical Site

    Krakow, 30-727, Poland

  • Clinical Site

    Lodz, 90-242, Poland

  • Clinical Site

    Nadarzyn, 05-830, Poland

  • Clinical Site

    Nowa Sól, 67-100, Poland

  • Clinical Site

    Olsztyn, 10-117, Poland

  • Clinical Site

    Poznan, 61-113, Poland

  • Clinical Site

    Sochaczew, 96-500, Poland

  • Clinical Site

    Swidnica, 58-100, Poland

  • Clinical Site

    Warsaw, 02-665, Poland

  • Clinical Site

    Madrid, 28100, Spain

  • Clinical Site

    Sabadell, 8208, Spain

  • Clinical Site

    Santiago de Compostela, 15702, Spain

  • Clinical Site

    Seville, 41010, Spain

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