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

Sponsor
MoonLake Immunotherapeutics AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05640245
Collaborator
(none)
200
11
5
14.6
18.2
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis
Actual Study Start Date :
Dec 13, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) [Week 12]

      Proportion of participants who achieve ACR50 compared with baseline

    Secondary Outcome Measures

    1. Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20) [Week 2, 4, 8, 12]

      Proportion of participants who achieve ACR20 compared with baseline

    2. Psoriasis Area and Severity Index (PASI) 90 [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 [Weeks 2, 4, 8, 12]

      Proportion of participants who achieve ACR70 compared with baseline

    4. Leeds Enthesitis Index (LEI) [Weeks 4, 8, 12]

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

    5. Leeds Dactylitis Index (LDI) [Weeks 4, 8, 12]

      Change from baseline for Leeds Dactylitis Index

    6. Modified Nail Psoriasis Severity Index (mNAPSI) [Week 12]

      Change from baseline for mNAPSI

    7. Psoriasis Area and Severity Index (PASI) 100 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Site Rancho Mirage California United States 92260
    2 Clinical Site Duncansville Pennsylvania United States 16635
    3 Clinical Site Plovdiv Bulgaria 4002
    4 Clinical Site Stara Zagora Bulgaria 6000
    5 Clinical Site Białystok Poland 15-879
    6 Clinical Site Nowa Sól Poland 67-100
    7 Clinical Site Olsztyn Poland 10-117
    8 Clinical Site Poznan Poland 61-113
    9 Clinical Site Swidnica Poland 58-100
    10 Clinical SIte Wrocław Poland 52-416
    11 Clinical Site Łódź Poland 90-242

    Sponsors and Collaborators

    • MoonLake Immunotherapeutics AG

    Investigators

    • Study Director: Kristian Reich, M.D., Ph.D. (equ.), MoonLake Immunotherapeutics AG

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MoonLake Immunotherapeutics AG
    ClinicalTrials.gov Identifier:
    NCT05640245
    Other Study ID Numbers:
    • M1095-PSA-201
    First Posted:
    Dec 7, 2022
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MoonLake Immunotherapeutics AG
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2023