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

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: Active, not recruiting
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: Sonelokimab; Drug: Placebo; Drug: Adalimumab

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

• Study Contact: Name: MoonLake ClinicalTrial Helpdesk; Phone Number: +41 41 510 8022; Email: clinicalTrials@moonlaketx.com

Study Locations

• Bulgaria
  • Pleven, Bulgaria, 5800
    • Clinical Site
  • Pleven, Bulgaria, 5803
    • Clinical Site
  • Plovdiv, Bulgaria, 4002
    • Clinical Site
  • Plovdiv, Bulgaria, 4003
    • Clinical Site
  • Ruse, 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
  • Szekesfehervar, Hungary, 8000
    • Clinical Site
  • Szentes, Hungary, 6600
    • Clinical Site
  • Veszprém, Hungary, 8200
    • Clinical Site
• Poland
  • Białystok, Poland, 15-879
    • Clinical Site
  • Białystok, Poland, 15-077
    • Clinical Site
  • Białystok, Poland, 15-351
    • Clinical Site
  • Bydgoszcz, Poland, 85-065
    • Clinical Site
  • Bydgoszcz, Poland, 85-168
    • Clinical Site
  • Elbląg, Poland, 82-300
    • Clinical Site
  • Gdynia, Poland, 81-338
    • Clinical Site
  • Kraków, Poland, 30-727
    • 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
  • Wrocław, Poland, 52-416
    • Clinical Site
  • Łódź, Poland, 90-242
    • Clinical Site
• Spain
  • Madrid, Spain, 28100
    • Clinical Site
  • Sabadell, Spain, 8208
    • Clinical Site
  • Santiago De Compostela, Spain, 15702
    • Clinical Site
  • Sevilla, 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

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

How is the study designed?

Design Details

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

Number of Arms

5

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
Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)	Proportion of participants who achieve ACR50 compared with baseline	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20)	Proportion of participants who achieve ACR20 compared with baseline	Week 2, 4, 8, 12
Psoriasis Area and Severity Index (PASI) 90	Proportion of participants who achieve PASI90 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline	Week 4, 8, 12
Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria	Proportion of participants who achieve ACR70 compared with baseline	Weeks 2, 4, 8, 12
Leeds Enthesitis Index (LEI)	Proportion of participants with resolution of enthesitis (LEI = 0)	Weeks 4, 8, 12
Leeds Dactylitis Index (LDI)	Change from baseline for Leeds Dactylitis Index	Weeks 4, 8, 12
Modified Nail Psoriasis Severity Index (mNAPSI)	Change from baseline for mNAPSI	Week 12
Psoriasis Area and Severity Index (PASI) 100	Proportion of participants who achieve PASI100 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline	Weeks 4, 8, 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): September 5, 2023
• Study Completion (Estimated): March 1, 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 (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Arthritis; Psoriasis; Joint Diseases; Skin Diseases; Arthritis, Psoriatic
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Anti-Inflammatory Agents; Antirheumatic Agents; Tumor Necrosis Factor Inhibitors; Adalimumab
• 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