Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis (NCT06865105) — Czechia Trial Details

Condition(s) studied

Psoriatic Arthritis

Investigational drug(s) / intervention(s)

Lutikizumab: Subcutaneous (SC) Injection

Risankizumab: Subcutaneous (SC) Injection

Study summary

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms.

The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: * Participant is willing and able to comply with procedures required in the Master Protocol and substudies. * Participant has a documented clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) at Screening Visit. * Participant has active disease defined as greater than or equal to 3 tender joints (based on 68 joint count) and greater than or equal to 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline. * Participant has active plaque PsO and/or a documented history of plaque PsO. * Participant must demonstrate intolerance or inadequate response to 1 to 2 targeted therapies (biologic or targeted synthetic disease-modifying antirheumatic drugs) approved for the treatment of PsA Exclusion Criteria: * Participants who have had major surgery performed within 12 weeks prior to randomization or plan to have a major surgery during conduct of the study (e.g., aneurysm removal, stomach ligation). * Participants with the following chronic or active infections: Are infected with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus(HCV) infection, active tuberculosis(TB) * Active skin disease other than psoriasis (PsO) which could interfere with the assessment of PsO. * History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).

Primary outcome measure(s)

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response — At Week 16
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Number of Participants With Adverse Events (AEs) — Up to Week 52
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Trial sites (37)

Facility	City	Region	Status
Newport Huntington Medical Group /ID# 272764	Huntington Beach	California	Recruiting
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085	Avon Park	Florida	Recruiting
Clinical Research Of West Florida - Phase I Unit /ID# 273198	Clearwater	Florida	Recruiting
HMD Research LLC /ID# 273086	Orlando	Florida	Recruiting
West Broward Rheumatology Associates /ID# 272892	Tamarac	Florida	Recruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199	Tampa	Florida	Recruiting
Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879	Skokie	Illinois	Recruiting
Willow Rheumatology and Wellness, PLLC /ID# 277354	Willowbrook	Illinois	Recruiting
Klein And Associates /ID# 272829	Hagerstown	Maryland	Completed
Paramount Medical Research and Consulting /ID# 272757	Middleburg Heights	Ohio	Recruiting
Altoona Center For Clinical Research /ID# 272593	Duncansville	Pennsylvania	Recruiting
Private Practice - Dr. Ramesh C. Gupta I /ID# 272897	Memphis	Tennessee	Recruiting
Tekton Research - West Gate /ID# 272765	Austin	Texas	Recruiting
Accurate Clinical Research - Houston /ID# 272754	Houston	Texas	Recruiting
Tekton Research, LLC /ID# 272901	San Antonio	Texas	Recruiting
Dynamed Clinical Research - Tomball /ID# 272760	Tomball	Texas	Recruiting
Centre de Recherche Musculo-Squelettique /ID# 274397	Trois-Rivières	Quebec	Recruiting
Dr. Latha Naik Medical Professional Corporation /ID# 272803	Saskatoon	Saskatchewan	Recruiting
Revmatologie /ID# 272367	Brno	Brno-mesto	Recruiting
L.K.N. Arthrocentrum /ID# 272366	Hlučín	Moravian-Silesian Region	Recruiting
Medical Plus s.r.o. /ID# 272363	Uherské Hradiště	Czechia	Recruiting
PV Medical Services s.r.o. /ID# 272368	Zlín	Czechia	Recruiting
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771	Nice	Alpes-Maritimes	Recruiting
Infirmerie Protestante De Lyon /ID# 273731	Caluire-et-Cuire	Auvergne-Rhône-Alpes	Recruiting
Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762	Chambray-lès-Tours	Indre-et-Loire	Recruiting
CHU Bordeaux - Hopital Pellegrin /ID# 273390	Bordeaux	New Aquitaine	Recruiting
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877	Orléans	France	Recruiting
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572	Miskolc	Borsod-Abauj Zemplen county	Recruiting
Complex Rendelo Med Zrt. /ID# 272570	Székesfehérvár	Fejér	Recruiting
Vital-Medicina Kft. /ID# 272855	Veszprém	Fejér	Recruiting
Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195	Budapest	Hungary	Recruiting
Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857	Budapest	Hungary	Recruiting
Mics Centrum Medyczne Bydgoszcz /ID# 273297	Bydgoszcz	Kuyavian-Pomeranian Voivodeship	Recruiting
MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305	Pruszków	Masovian Voivodeship	Recruiting
Centrum Medyczne Reuma Park /ID# 273301	Warsaw	Masovian Voivodeship	Recruiting
Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304	Bialystok	Podlaskie Voivodeship	Recruiting
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306	Elblag	Warmian-Masurian Voivodeship	Recruiting

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