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

Arthritis, Psoriatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640245
• Other study ID #: M1095-PSA-201
• Status: Completed
• Phase: Phase 2
• Start date: December 13, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: November 2023
• Source: MoonLake Immunotherapeutics AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 15, 2024
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (TNFa) 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• Sonelokimab
randomized treatment; parallel group
• Placebo
randomized treatment; parallel-group
• Adalimumab
randomized treatment; parallel-group

Locations

Country	Name	City	State
Bulgaria	Clinical Site	Pleven
Bulgaria	Clinical Site	Pleven
Bulgaria	Clinical Site	Plovdiv
Bulgaria	Clinical Site	Plovdiv
Bulgaria	Clinical Site	Ruse
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Stara Zagora
Bulgaria	Clinical Site	Varna
Czechia	Clinical Site	Ostrava
Estonia	Clinical Site	Tallinn
Estonia	Clinical Site	Tartu
Germany	Clinical Site	Hamburg
Germany	Clinical Site	Herne
Hungary	Clinical Site	Budapest
Hungary	Clinical Site	Budapest
Hungary	Clinical Site	Budapest
Hungary	Clinical Site	Szekesfehervar
Hungary	Clinical Site	Szentes
Hungary	Clinical Site	Veszprém
Poland	Clinical Site	Bialystok
Poland	Clinical Site	Bialystok
Poland	Clinical Site	Bialystok
Poland	Clinical Site	Bydgoszcz
Poland	Clinical Site	Bydgoszcz
Poland	Clinical Site	Elblag
Poland	Clinical Site	Gdynia
Poland	Clinical Site	Kraków
Poland	Clinical Site	Lódz
Poland	Clinical Site	Nadarzyn
Poland	Clinical Site	Nowa Sól
Poland	Clinical Site	Olsztyn
Poland	Clinical Site	Poznan
Poland	Clinical Site	Sochaczew
Poland	Clinical Site	Swidnica
Poland	Clinical Site	Warsaw
Poland	Clinical SIte	Wroclaw
Spain	Clinical Site	Madrid
Spain	Clinical Site	Sabadell
Spain	Clinical Site	Santiago De Compostela
Spain	Clinical Site	Sevilla
United States	Clinical Site	Duncansville	Pennsylvania
United States	Clinical Site	Rancho Mirage	California

Sponsors (1)

Lead Sponsor	Collaborator
MoonLake Immunotherapeutics AG

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Estonia,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Leeds Enthesitis Index (LEI)	Proportion of participants with resolution of enthesitis (LEI = 0)	Weeks 4, 8, 12
Secondary	Leeds Dactylitis Index (LDI)	Change from baseline for Leeds Dactylitis Index	Weeks 4, 8, 12
Secondary	Modified Nail Psoriasis Severity Index (mNAPSI)	Change from baseline for mNAPSI	Week 12
Secondary	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