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

NCT ID: NCT05640245

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2024-01-15

Brief Summary

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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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Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis

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Detailed Description

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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.

Conditions

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Arthritis, Psoriatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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sonelokimab dose regimen 1

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1

Group Type EXPERIMENTAL

Sonelokimab

Intervention Type DRUG

randomized treatment; parallel group

sonelokimab dose regimen 2

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2

Group Type EXPERIMENTAL

Sonelokimab

Intervention Type DRUG

randomized treatment; parallel group

sonelokimab dose regimen 3

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3

Group Type EXPERIMENTAL

Sonelokimab

Intervention Type DRUG

randomized treatment; parallel group

Placebo

Subjects randomized to this arm will receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

randomized treatment; parallel-group

adalimumab

Subjects randomized to this arm will receive adalimumab

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type DRUG

randomized treatment; parallel-group

Interventions

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Sonelokimab

randomized treatment; parallel group

Intervention Type DRUG

Placebo

randomized treatment; parallel-group

Intervention Type DRUG

Adalimumab

randomized treatment; parallel-group

Intervention Type DRUG

Other Intervention Names

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M1095

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MoonLake Immunotherapeutics AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristian Reich, M.D., Ph.D. (equ.)

Role: STUDY_DIRECTOR

MoonLake Immunotherapeutics AG

Locations

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Clinical Site

Rancho Mirage, California, United States

Site Status

Clinical Site

Duncansville, Pennsylvania, United States

Site Status

Clinical Site

Pleven, , Bulgaria

Site Status

Clinical Site

Pleven, , Bulgaria

Site Status

Clinical Site

Plovdiv, , Bulgaria

Site Status

Clinical Site

Plovdiv, , Bulgaria

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Clinical Site

Rousse, , Bulgaria

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Clinical Site

Sofia, , Bulgaria

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Clinical Site

Stara Zagora, , Bulgaria

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Clinical Site

Varna, , Bulgaria

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Clinical Site

Ostrava, , Czechia

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Clinical Site

Tallinn, , Estonia

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Clinical Site

Tartu, , Estonia

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Clinical Site

Hamburg, , Germany

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Clinical Site

Herne, , Germany

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Clinical Site

Budapest, , Hungary

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Clinical Site

Budapest, , Hungary

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Clinical Site

Budapest, , Hungary

Site Status

Clinical Site

Szentes, , Hungary

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Clinical Site

Székesfehérvár, , Hungary

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Clinical Site

Veszprém, , Hungary

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Clinical Site

Bialystok, , Poland

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Clinical Site

Bialystok, , Poland

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Clinical Site

Bialystok, , Poland

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Clinical Site

Bydgoszcz, , Poland

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Clinical Site

Bydgoszcz, , Poland

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Clinical Site

Elblag, , Poland

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Clinical Site

Gdynia, , Poland

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Clinical Site

Krakow, , Poland

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Clinical Site

Lodz, , Poland

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Clinical Site

Nadarzyn, , Poland

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Clinical Site

Nowa Sól, , Poland

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Clinical Site

Olsztyn, , Poland

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Clinical Site

Poznan, , Poland

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Clinical Site

Sochaczew, , Poland

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Clinical Site

Swidnica, , Poland

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Clinical Site

Warsaw, , Poland

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Clinical SIte

Wroclaw, , Poland

Site Status

Clinical Site

Madrid, , Spain

Site Status

Clinical Site

Sabadell, , Spain

Site Status

Clinical Site

Santiago de Compostela, , Spain

Site Status

Clinical Site

Seville, , Spain

Site Status

Countries

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United States Bulgaria Czechia Estonia Germany Hungary Poland Spain

References

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McInnes IB, Coates LC, Mease PJ, Ogdie A, Kavanaugh A, Eder L, Schett G, Kivitz A, McGonagle D, Brennan N, Godwood A, Cullen E, Reich K, Ritchlin CT, Merola JF. Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial. Nat Med. 2025 Oct 6. doi: 10.1038/s41591-025-03971-6. Online ahead of print.

Reference Type DERIVED
PMID: 41053449 (View on PubMed)

Other Identifiers

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M1095-PSA-201

Identifier Type: -

Identifier Source: org_study_id

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