Targeted therapies for treating active psoriatic arthritis in adults
A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis
This study is testing if two different treatments for active psoriatic arthritis can help adults feel better and improve their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | risankizumab, lutikizumab |
| Locations | 37 sites (Huntington Beach, California and 36 other locations) |
| Trial ID | NCT06865105 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of targeted therapies for adults with active psoriatic arthritis (PsA). Participants will be randomized into three treatment arms: lutikizumab monotherapy, risankizumab monotherapy, or a combination of both therapies. The study aims to assess changes in disease symptoms and will enroll approximately 120 participants across 40 sites worldwide. Participants will undergo regular visits and procedures throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults with a documented diagnosis of active psoriatic arthritis who have not responded adequately to previous targeted therapies.
Not a fit: Patients who have not experienced inadequate responses to prior treatments or have had major surgeries recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new effective treatment options for patients suffering from active psoriatic arthritis.
How similar studies have performed: Other studies have shown promise with targeted therapies for psoriatic arthritis, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Huntington Beach, California and 36 other locations
- Newport Huntington Medical Group /ID# 272764 — Huntington Beach, California, United States (Recruiting)
- Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085 — Avon Park, Florida, United States (Recruiting)
- Clinical Research Of West Florida - Phase I Unit /ID# 273198 — Clearwater, Florida, United States (Recruiting)
- HMD Research LLC /ID# 273086 — Orlando, Florida, United States (Recruiting)
- West Broward Rheumatology Associates /ID# 272892 — Tamarac, Florida, United States (Recruiting)
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199 — Tampa, Florida, United States (Recruiting)
- Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879 — Skokie, Illinois, United States (Recruiting)
- Willow Rheumatology and Wellness, PLLC /ID# 277354 — Willowbrook, Illinois, United States (Recruiting)
- Klein And Associates /ID# 272829 — Hagerstown, Maryland, United States (Completed)
- Paramount Medical Research and Consulting /ID# 272757 — Middleburg Heights, Ohio, United States (Recruiting)
- Altoona Center For Clinical Research /ID# 272593 — Duncansville, Pennsylvania, United States (Recruiting)
- Private Practice - Dr. Ramesh C. Gupta I /ID# 272897 — Memphis, Tennessee, United States (Recruiting)
- Tekton Research - West Gate /ID# 272765 — Austin, Texas, United States (Recruiting)
- Accurate Clinical Research - Houston /ID# 272754 — Houston, Texas, United States (Recruiting)
- Tekton Research, LLC /ID# 272901 — San Antonio, Texas, United States (Recruiting)
- Dynamed Clinical Research - Tomball /ID# 272760 — Tomball, Texas, United States (Recruiting)
- Centre de Recherche Musculo-Squelettique /ID# 274397 — Trois-Rivières, Quebec, Canada (Recruiting)
- Dr. Latha Naik Medical Professional Corporation /ID# 272803 — Saskatoon, Saskatchewan, Canada (Recruiting)
- Revmatologie /ID# 272367 — Brno, Brno-mesto, Czechia (Recruiting)
- L.K.N. Arthrocentrum /ID# 272366 — Hlučín, Moravian-Silesian Region, Czechia (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, France (Recruiting)
- Infirmerie Protestante De Lyon /ID# 273731 — Caluire-et-Cuire, Auvergne-Rhône-Alpes, France (Recruiting)
- Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762 — Chambray-lès-Tours, Indre-et-Loire, France (Recruiting)
- CHU Bordeaux - Hopital Pellegrin /ID# 273390 — Bordeaux, New Aquitaine, France (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, Hungary (Recruiting)
- Complex Rendelo Med Zrt. /ID# 272570 — Székesfehérvár, Fejér, Hungary (Recruiting)
- Vital-Medicina Kft. /ID# 272855 — Veszprém, Fejér, Hungary (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, Poland (Recruiting)
- MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305 — Pruszków, Masovian Voivodeship, Poland (Recruiting)
- Centrum Medyczne Reuma Park /ID# 273301 — Warsaw, Masovian Voivodeship, Poland (Recruiting)
- Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304 — Bialystok, Podlaskie Voivodeship, Poland (Recruiting)
- Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306 — Elblag, Warmian-Masurian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.