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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-Study 1: Risankizumab Monotherapy | Experimental | Participants will receive Risankizumab |
|
| Sub-Study 1: Lutikizumab Monotherapy | Experimental | Participants will initially receive Lutikizumab Dose A followed by Lutikizumab Dose B every other week. |
|
| SubStudy 1: Lutikizumab and Risankizumab Combination Therapy | Experimental | Participants will be administered Lutikizumab and Risankizumab at the same time following the same dosing regimen as the monotherapy arms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutikizumab | Drug | Subcutaneous (SC) Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| At Week 16 |
| Number of Participants With Adverse Events (AEs) | 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. | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Minimal Disease Activity (MDA) Response | A participant was classified as achieving MDA if 5 of the following 7 criteria were met:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Huntington Medical Group /ID# 272764 | Recruiting | Huntington Beach | California | 92648-5994 | United States |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Risankizumab | Drug | Subcutaneous (SC) Injection |
|
| At Week 16 |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| At Week 16 |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
| At Week 16 |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response (in the subset of participants with a PsO BSA ≥ 3% at Baseline) | PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score, and was assessed in participants with Baseline psoriasis BSA involvement ≥ 3%. | At Week 16 |
| Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085 | Recruiting | Avon Park | Florida | 33825 | United States |
|
| Clinical Research Of West Florida - Phase I Unit /ID# 273198 | Recruiting | Clearwater | Florida | 33765 | United States |
| HMD Research LLC /ID# 273086 | Recruiting | Orlando | Florida | 32819 | United States |
| West Broward Rheumatology Associates /ID# 272892 | Recruiting | Tamarac | Florida | 33321 | United States |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199 | Recruiting | Tampa | Florida | 33606 | United States |
|
| Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879 | Recruiting | Skokie | Illinois | 60076 | United States |
|
| Willow Rheumatology and Wellness, PLLC /ID# 277354 | Recruiting | Willowbrook | Illinois | 60527 | United States |
| Klein And Associates /ID# 272829 | Completed | Hagerstown | Maryland | 21740 | United States |
| Paramount Medical Research and Consulting /ID# 272757 | Recruiting | Middleburg Heights | Ohio | 44130 | United States |
| Altoona Center For Clinical Research /ID# 272593 | Recruiting | Duncansville | Pennsylvania | 16635 | United States |
|
| Private Practice - Dr. Ramesh C. Gupta I /ID# 272897 | Recruiting | Memphis | Tennessee | 38119 | United States |
| Tekton Research - West Gate /ID# 272765 | Recruiting | Austin | Texas | 78745 | United States |
| Accurate Clinical Research - Houston /ID# 272754 | Recruiting | Houston | Texas | 77089-6142 | United States |
|
| Tekton Research, LLC /ID# 272901 | Recruiting | San Antonio | Texas | 78251 | United States |
| Dynamed Clinical Research - Tomball /ID# 272760 | Recruiting | Tomball | Texas | 77375 | United States |
| Centre de Recherche Musculo-Squelettique /ID# 274397 | Recruiting | Trois-Rivières | Quebec | G9A 3X2 | Canada |
| Dr. Latha Naik Medical Professional Corporation /ID# 272803 | Recruiting | Saskatoon | Saskatchewan | S7H 0P4 | Canada |
| Revmatologie /ID# 272367 | Recruiting | Brno | Brno-mesto | 638 00 | Czechia |
| L.K.N. Arthrocentrum /ID# 272366 | Recruiting | Hlučín | Moravian-Silesian Region | 748 01 | Czechia |
| Medical Plus s.r.o. /ID# 272363 | Recruiting | Uherské Hradiště | 686 01 | Czechia |
| PV Medical Services s.r.o. /ID# 272368 | Recruiting | Zlín | 760 01 | Czechia |
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771 | Recruiting | Nice | Alpes-Maritimes | 06001 | France |
| Infirmerie Protestante De Lyon /ID# 273731 | Recruiting | Caluire-et-Cuire | Auvergne-Rhône-Alpes | 69300 | France |
| Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762 | Recruiting | Chambray-lès-Tours | Indre-et-Loire | 37170 | France |
| CHU Bordeaux - Hopital Pellegrin /ID# 273390 | Recruiting | Bordeaux | New Aquitaine | 33076 | France |
| Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877 | Recruiting | Orléans | 45067 | France |
| Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572 | Recruiting | Miskolc | Borsod-Abauj Zemplen county | 3529 | Hungary |
| Complex Rendelo Med Zrt. /ID# 272570 | Recruiting | Székesfehérvár | Fejér | 8000 | Hungary |
| Vital-Medicina Kft. /ID# 272855 | Recruiting | Veszprém | Fejér | 8200 | Hungary |
| Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195 | Recruiting | Budapest | 1023 | Hungary |
| Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857 | Recruiting | Budapest | 1027 | Hungary |
| Mics Centrum Medyczne Bydgoszcz /ID# 273297 | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-068 | Poland |
| MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305 | Recruiting | Pruszków | Masovian Voivodeship | 05-800 | Poland |
| Centrum Medyczne Reuma Park /ID# 273301 | Recruiting | Warsaw | Masovian Voivodeship | 02-665 | Poland |
| Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304 | Recruiting | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306 | Recruiting | Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000655035 | lutikizumab |
| C000601773 | risankizumab |
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