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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MoonLake Immunotherapeutics AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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