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OpenTrials
Completed

NCT Number: NCT05640245

Evaluation of Sonelokimab for the Treatment of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Site, Pleven, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Sonelokimab

Drug

randomized treatment; parallel group

Other names: M1095

Placebo

Drug

randomized treatment; parallel-group

Adalimumab

Drug

randomized treatment; parallel-group

Primary outcomes

  1. Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)

    Time frame: Week 12

    Proportion of participants who achieve ACR50 compared with baseline

Secondary outcomes

  1. Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20)

    Time frame: Week 2, 4, 8, 12

    Proportion of participants who achieve ACR20 compared with baseline

  2. Psoriasis Area and Severity Index (PASI) 90

    Time frame: Week 4, 8, 12

    Proportion of participants who achieve PASI90 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline

  3. Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria

    Time frame: Weeks 2, 4, 8, 12

    Proportion of participants who achieve ACR70 compared with baseline

  4. Leeds Enthesitis Index (LEI)

    Time frame: Weeks 4, 8, 12

    Proportion of participants with resolution of enthesitis (LEI = 0)

  5. Leeds Dactylitis Index (LDI)

    Time frame: Weeks 4, 8, 12

    Change from baseline for Leeds Dactylitis Index

  6. Modified Nail Psoriasis Severity Index (mNAPSI)

    Time frame: Week 12

    Change from baseline for mNAPSI

  7. Psoriasis Area and Severity Index (PASI) 100

    Time frame: Weeks 4, 8, 12

    Proportion of participants who achieve PASI100 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline

Sponsors and collaborators

Lead sponsor

MoonLake Immunotherapeutics AG

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 7, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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