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

NCT05640245 | Completed Phase 2 Results FDA Drug

• 1 other identifier: M1095-PSA-201
• Study Type: interventional
• Target: 207
• Locations: 7 countries
• Sites: 38

Brief 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.

Conditions

Arthritis, Psoriatic

Keywords

Arthritis, Psoriatic; Skin Diseases; Joint Diseases; Arthritis; Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12

  The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) participant's assessment of arthritis pain (PtAAP) on a Visual Analog Scale (VAS, no pain =0 to severe pain =100); 2) participant's global assessment of disease activity (PtGADA) on a VAS (very well =0 to very poor =100); 3) physician's global assessment of disease activity (phGADA) on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) (overall score ranging from 0 \[mild disability\] to 3 \[very severe disability\]); and 5) high sensitivity C-reactive protein (hs-CRP, decrease indicates improvement). A non-responder imputation (NRI) method was used for missing data.

  At Week 12

Secondary Outcomes (8)

• Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, and 8 and 12

  At Weeks 2, 4, 8, and 12

• Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 4, 8 and 12, in Participants With Psoriasis Involving at Least 3% Body Surface Area (BSA) at Baseline

  At Weeks 4, 8, and 12

• Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, and 8

  At Weeks 2, 4, and 8

• Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 2, 4, 8, and 12

  At Weeks 2, 4, 8, and 12

• Percentage of Participants Achieving Minimal Disease Activity at Week 12

  At Week 12

Study Arms (5)

sonelokimab dose regimen 1

EXPERIMENTAL

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1

Drug: Sonelokimab

sonelokimab dose regimen 2

EXPERIMENTAL

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2

Drug: Sonelokimab

sonelokimab dose regimen 3

EXPERIMENTAL

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3

Drug: Sonelokimab

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will receive placebo

Drug: Placebo

adalimumab

ACTIVE COMPARATOR

Subjects randomized to this arm will receive adalimumab

Drug: Adalimumab

Interventions

Sonelokimab DRUG

randomized treatment; parallel group

Also known as: M1095

sonelokimab dose regimen 1; sonelokimab dose regimen 2; sonelokimab dose regimen 3

Placebo DRUG

randomized treatment; parallel-group

Placebo

Adalimumab DRUG

randomized treatment; parallel-group

adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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;
• Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA;
• Participant who has a diagnosis of arthritis mutilans

Sponsors & Collaborators

• MoonLake Immunotherapeutics AG: lead

Study Sites (42)

Clinical Site

Rancho Mirage, California, 92260, United States

Location

Clinical Site

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Site

Pleven, 5800, Bulgaria

Location

Clinical Site

Pleven, 5803, Bulgaria

Location

Clinical Site

Plovdiv, 4002, Bulgaria

Location

Clinical Site

Plovdiv, 4003, Bulgaria

Location

Clinical Site

Rousse, 7002, Bulgaria

Location

Clinical Site

Sofia, 1336, Bulgaria

Location

Clinical Site

Stara Zagora, 6000, Bulgaria

Location

Clinical Site

Varna, 9000, Bulgaria

Location

Clinical Site

Ostrava, 702 00, Czechia

Location

Clinical Site

Tallinn, 10128, Estonia

Location

Clinical Site

Tartu, 20708, Estonia

Location

Clinical Site

Hamburg, 20095, Germany

Location

Clinical Site

Herne, 44649, Germany

Location

Clinical Site

Budapest, 1023, Hungary

Location

Clinical Site

Budapest, 1027, Hungary

Location

Clinical Site

Budapest, 1036, Hungary

Location

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Szentes, 6600, Hungary

Location

Clinical Site

Székesfehérvár, 8000, Hungary

Location

Clinical Site

Veszprém, 8200, Hungary

Location

Clinical Site

Bialystok, 15-077, Poland

Location

Clinical Site

Bialystok, 15-351, Poland

Location

Clinical Site

Bialystok, 15-879, Poland

Location

Clinical Site

Bydgoszcz, 85-065, Poland

Location

Clinical Site

Bydgoszcz, 85-168, Poland

Location

Clinical Site

Elblag, 82-300, Poland

Location

Clinical Site

Gdynia, 81-338, Poland

Location

Clinical Site

Krakow, 30-727, Poland

Location

Clinical Site

Lodz, 90-242, Poland

Location

Clinical Site

Nadarzyn, 05-830, Poland

Location

Clinical Site

Nowa Sól, 67-100, Poland

Location

Clinical Site

Olsztyn, 10-117, Poland

Location

Clinical Site

Poznan, 61-113, Poland

Location

Clinical Site

Sochaczew, 96-500, Poland

Location

Clinical Site

Swidnica, 58-100, Poland

Location

Clinical Site

Warsaw, 02-665, Poland

Location

Clinical SIte

Wroclaw, 52-416, Poland

Location

Clinical Site

Madrid, 28100, Spain

Location

Clinical Site

Sabadell, 8208, Spain

Location

Clinical Site

Santiago de Compostela, 15702, Spain

Location

Clinical Site

Seville, 41010, Spain

Location

Related Publications (1)

• McInnes IB, Coates LC, Mease PJ, Ogdie A, Kavanaugh A, Eder L, Schett G, Kivitz A, McGonagle D, Brennan N, Godwood A, Cullen E, Reich K, Ritchlin CT, Merola JF. Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial. Nat Med. 2025 Dec;31(12):4160-4171. doi: 10.1038/s41591-025-03971-6. Epub 2025 Oct 6.

  PMID: 41053449 RESULT

MeSH Terms

Conditions

Arthritis, Psoriatic; Skin Diseases; Joint Diseases; Arthritis; Psoriasis

Interventions

sonelokimab; Adalimumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: MoonLake Regulatory Affairs
• Organization: MoonLake Immunotherapeutics AG

regulatory@moonlaketx.com

+41 782066864

Study Officials

• MD

  MoonLake Immunotherapeutics AG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: December 13, 2022
• Primary Completion: September 5, 2023
• Study Completion: January 15, 2024
• Last Updated: September 10, 2026
• Results First Posted: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HU (6); PL (17); ES (2); US (2); DE (2); CZ (1); BU (8)