Clinical trial NCT05640245: Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis
Official title: Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Psoriatic
Keywords: Arthritis, Psoriatic
Skin Diseases
Joint Diseases
Arthritis
Psoriasis
Lead sponsor: MoonLake Immunotherapeutics AG
Sponsor class: INDUSTRY
First posted: 2022-12-07
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
timeFrame: Week 12
Secondary outcomes:
measure: Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20)
timeFrame: Week 2, 4, 8, 12
measure: Psoriasis Area and Severity Index (PASI) 90
timeFrame: Week 4, 8, 12
measure: Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria
timeFrame: Weeks 2, 4, 8, 12
measure: Leeds Enthesitis Index (LEI)
timeFrame: Weeks 4, 8, 12
measure: Leeds Dactylitis Index (LDI)
timeFrame: Weeks 4, 8, 12
measure: Modified Nail Psoriasis Severity Index (mNAPSI)
timeFrame: Week 12
measure: Psoriasis Area and Severity Index (PASI) 100
timeFrame: Weeks 4, 8, 12
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Clinical Site
state: California
city: Duncansville
country: United States
facility: Clinical Site
state: Pennsylvania
city: Pleven
country: Bulgaria
facility: Clinical Site
city: Pleven
country: Bulgaria
facility: Clinical Site
city: Plovdiv
country: Bulgaria
facility: Clinical Site
city: Plovdiv
country: Bulgaria
facility: Clinical Site
city: Ruse
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Stara Zagora
country: Bulgaria
facility: Clinical Site
city: Varna
country: Bulgaria
facility: Clinical Site
city: Ostrava
country: Czechia
facility: Clinical Site
city: Tallinn
country: Estonia
facility: Clinical Site
city: Tartu
country: Estonia
facility: Clinical Site
city: Hamburg
country: Germany
facility: Clinical Site
city: Herne
country: Germany
facility: Clinical Site
city: Budapest
country: Hungary
facility: Clinical Site
city: Budapest
country: Hungary
facility: Clinical Site
city: Budapest
country: Hungary
facility: Clinical Site
city: Szekesfehervar
country: Hungary
facility: Clinical Site
city: Szentes
country: Hungary
facility: Clinical Site
city: Veszprém
country: Hungary
facility: Clinical Site
city: Białystok
country: Poland
facility: Clinical Site
city: Białystok
country: Poland
facility: Clinical Site
city: Białystok
country: Poland
facility: Clinical Site
city: Bydgoszcz
country: Poland
facility: Clinical Site
city: Bydgoszcz
country: Poland
facility: Clinical Site
city: Elbląg
country: Poland
facility: Clinical Site
city: Gdynia
country: Poland
facility: Clinical Site
city: Kraków
country: Poland
facility: Clinical Site
city: Nadarzyn
country: Poland
facility: Clinical Site
city: Nowa Sól
country: Poland
facility: Clinical Site
city: Olsztyn
country: Poland
facility: Clinical Site
city: Poznan
country: Poland
facility: Clinical Site
city: Sochaczew
country: Poland
facility: Clinical Site
city: Swidnica
country: Poland
facility: Clinical Site
city: Warsaw
country: Poland
facility: Clinical Site
city: Wrocław
country: Poland
facility: Clinical SIte
city: Łódź
country: Poland
facility: Clinical Site
city: Madrid
country: Spain
facility: Clinical Site
city: Sabadell
country: Spain
facility: Clinical Site
city: Santiago De Compostela
country: Spain
facility: Clinical Site
city: Sevilla
country: Spain
facility: Clinical Site
Study officials:
affiliation: MoonLake Immunotherapeutics AG
name: Kristian Reich, M.D., Ph.D. (equ.)
role: STUDY_DIRECTOR
References: