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

August 17, 2026 updated by: MoonLake Immunotherapeutics AG

Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Clinical Site
      • Pleven, Bulgaria, 5803
        • Clinical Site
      • Plovdiv, Bulgaria, 4002
        • Clinical Site
      • Plovdiv, Bulgaria, 4003
        • Clinical Site
      • Rousse, Bulgaria, 7002
        • Clinical Site
      • Sofia, Bulgaria, 1336
        • Clinical Site
      • Stara Zagora, Bulgaria, 6000
        • Clinical Site
      • Varna, Bulgaria, 9000
        • Clinical Site
  • Czechia
      • Ostrava, Czechia, 702 00
        • Clinical Site
  • Estonia
      • Tallinn, Estonia, 10128
        • Clinical Site
      • Tartu, Estonia, 20708
        • Clinical Site
  • Germany
      • Hamburg, Germany, 20095
        • Clinical Site
      • Herne, Germany, 44649
        • Clinical Site
  • Hungary
      • Budapest, Hungary, 1023
        • Clinical Site
      • Budapest, Hungary, 1027
        • Clinical Site
      • Budapest, Hungary, 1036
        • Clinical Site
      • Szentes, Hungary, 6600
        • Clinical Site
      • Székesfehérvár, Hungary, 8000
        • Clinical Site
      • Veszprém, Hungary, 8200
        • Clinical Site
  • Poland
      • Bialystok, Poland, 15-879
        • Clinical Site
      • Bialystok, Poland, 15-077
        • Clinical Site
      • Bialystok, Poland, 15-351
        • Clinical Site
      • Bydgoszcz, Poland, 85-065
        • Clinical Site
      • Bydgoszcz, Poland, 85-168
        • Clinical Site
      • Elblag, Poland, 82-300
        • Clinical Site
      • Gdynia, Poland, 81-338
        • Clinical Site
      • Krakow, Poland, 30-727
        • Clinical Site
      • Lodz, Poland, 90-242
        • Clinical Site
      • Nadarzyn, Poland, 05-830
        • Clinical Site
      • Nowa Sól, Poland, 67-100
        • Clinical Site
      • Olsztyn, Poland, 10-117
        • Clinical Site
      • Poznan, Poland, 61-113
        • Clinical Site
      • Sochaczew, Poland, 96-500
        • Clinical Site
      • Swidnica, Poland, 58-100
        • Clinical Site
      • Warsaw, Poland, 02-665
        • Clinical Site
      • Wroclaw, Poland, 52-416
        • Clinical Site
  • Spain
      • Madrid, Spain, 28100
        • Clinical Site
      • Sabadell, Spain, 8208
        • Clinical Site
      • Santiago de Compostela, Spain, 15702
        • Clinical Site
      • Seville, Spain, 41010
        • Clinical Site
  • United States
    • California
      • Rancho Mirage, California, United States, 92260
        • Clinical Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sonelokimab dose regimen 1
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1
Drug: Sonelokimab
randomized treatment; parallel group
Other Names:
  • M1095
Experimental: sonelokimab dose regimen 2
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2
Drug: Sonelokimab
randomized treatment; parallel group
Other Names:
  • M1095
Experimental: sonelokimab dose regimen 3
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3
Drug: Sonelokimab
randomized treatment; parallel group
Other Names:
  • M1095
Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo
Drug: Placebo
randomized treatment; parallel-group
Active Comparator: adalimumab
Subjects randomized to this arm will receive adalimumab
Drug: Adalimumab
randomized treatment; parallel-group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, and 8 and 12
Time Frame: At Weeks 2, 4, 8, and 12
The ACR20 response criteria was a response of at least 20% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 20% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data. ACR20 response rate at Week 12 was analyzed as a key secondary outcome measure.
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
Time Frame: At Weeks 4, 8, and 12
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI90 response was defined as greater than or equal to 90% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data. PASI90 response at Week 12 was analyzed as a key secondary outcome measure.
At Weeks 4, 8, and 12
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, and 8
Time Frame: At Weeks 2, 4, and 8
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) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data.
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
Time Frame: At Weeks 2, 4, 8, and 12
The ACR70 response criteria was a response of at least 70% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 70% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data.
At Weeks 2, 4, 8, and 12
Percentage of Participants Achieving Minimal Disease Activity at Week 12
Time Frame: At Week 12
Minimal disease activity was defined as meeting 5 of the following 7 criteria: tender joint count (68 joints) ≤1; swollen joint count (66 joints) ≤1; psoriasis area and severity index ≤1 or psoriasis affecting ≤1% of body surface area; PtAAP ≤15 on a VAS (0 = no pain to 100 = severe pain); PtGADA ≤20 on a VAS (0 = very well to 100 = very poor); HAQ-DI ≤0.5 (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and Leeds Enthesitis Index (LEI) ≤1 (overall score ranging from 0 to 6, with higher scores indicating greater disease severity). An NRI method was used for missing data.
At Week 12
Percentage of Participants Who Achieved a PASI75 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
Time Frame: At Week 12
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI75 response was defined as greater than or 75% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data.
At Week 12
Percentage of Participants Achieving a PASI100 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
Time Frame: At Week 12
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI100 response was defined as 100% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data.
At Week 12
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 12
Time Frame: Baseline and Week 12
The mNAPSI is a tool to assess psoriatic nail involvement. Three groups of features (pitting, onycholysis, and oil-drop dyshromia and crumbling) for each fingernail are graded on a scale from 0 to 3. Four features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula) are graded as either present (1) or absent (0) in each fingernail. The total score was calculated by summing the score for each feature and each fingernail and ranged from 0 to 130, with higher scores indicating greater nail disease. A negative change from baseline indicated an improvement in nail disease.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MoonLake Immunotherapeutics AG

Investigators

  • Study Director: MD, MoonLake Immunotherapeutics AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2022

Primary Completion (Actual)

September 5, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

November 28, 2022

First Posted (Actual)

December 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M1095-PSA-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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