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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05640245
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	MoonLake Immunotherapeutics AG
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kristian Reich, M.D., Ph.D. (equ.)
Principal Investigator Affiliation	MoonLake Immunotherapeutics AG
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Bulgaria, Czechia, Estonia, Germany, Hungary, Poland, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthritis, Psoriatic

Additional Details

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.

Arms & Interventions

Arms

Experimental: sonelokimab dose regimen 1

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

Experimental: sonelokimab dose regimen 2

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

Experimental: sonelokimab dose regimen 3

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

Placebo Comparator: Placebo

Subjects randomized to this arm will receive placebo

Active Comparator: adalimumab

Subjects randomized to this arm will receive adalimumab

Interventions

Drug: - Sonelokimab

randomized treatment; parallel group

Drug: - Placebo

randomized treatment; parallel-group

Drug: - Adalimumab

randomized treatment; parallel-group

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Site, Rancho Mirage, California

Status

Recruiting

Address

Clinical Site

Rancho Mirage, California, 92260

Site Contact

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