A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
Who is this study for? Patients with Giant Cell Arteritis
What treatments are being studied? Guselkumab
Status: Terminated
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Diagnosis of Giant cell arteritis (GCA) according to the revised American College of Rheumatology criteria
• GCA diagnosis confirmed by either temporal artery biopsy revealing features of GCA either at time of diagnosis or at other timepoint during disease history; or evidence of cranial GCA either at time of diagnosis or at other timepoint during disease history by cranial doppler-ultrasound; or cranial Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography; or other imaging modality upon agreement with the sponsor or evidence of GCA by angiography or cross-sectional imaging (ultrasound, MRI, computed tomography \[CT\], positron emission tomography \[PET\])
• Have new onset or relapsing GCA
• Have active GCA within 6 weeks of first study intervention: Active GCA: presence of signs and symptoms of GCA and elevated erythrocyte sedimentation rate (ESR) greater than or equal to (\>=) 30 millimeter per hour (mm/hour), or C-reactive protein (CRP) \>= 10 milligrams per liter (mg/L) (or 1 milligrams per deciliter \[mg/dL\]), attributed to active GCA. ESR \>= 30 mm/hour or CRP \>= 10 mg/L (or 1 mg/dL) is not required if active GCA has been confirmed by a positive temporal artery biopsy or ultrasound or other imaging modality within 6 weeks of first study intervention
• Clinically stable GCA disease on a glucocorticoid (GC) dose between 20 and 60 milligrams per day (mg/day) (prednisone or equivalent) at randomization such that the participant is able to safely participate in the protocol defined prednisone taper regimen, in the opinion of the investigator
Locations
United States
Kansas
University of Kansas Medical Center
Kansas City
Massachusetts
Massachusetts General Hospital
Boston
Other Locations
Belgium
Cliniques Universitaires St-Luc
Brussels
UZ Leuven Gasthuisberg
Leuven
Canada
Hopital du Sacre-Coeur de Montreal
Montreal
Mount Sinai Hospital
Toronto
France
CHU Dijon
Dijon
Hopital Cochin
Paris
Germany
Universitatsklinikum Erlangen
Erlangen
medius KLINIK KIRCHHEIM
Kirchheim Unter Teck
Universitatsklinik Tubingen
Tübingen
Israel
Bnai Zion Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Rabin Medical Center Beilinson Campus
Petah Tikva
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico
Bolzano
Ospedale San Raffaele
Milan
Azienda Ospedaliera di Padova
Padua
Fondazione IRCCS Policlinico San Matteo
Pavia
Azienda USL 4 Prato
Prato
ASUI Santa Maria della Misericordia di Udine
Udine
Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz
Szpital Specjalistyczny im. J. Dietla
Krakow
NZOZ Lecznica MAK MED S C
Nadarzyn
Spain
Hosp Univ A Coruna
A Coruña
Hosp Clinic de Barcelona
Barcelona
Hosp. Clinico San Carlos
Madrid
Hosp. Univ. 12 de Octubre
Madrid
Hosp Regional Univ de Malaga
Málaga
Hosp. Univ. Marques de Valdecilla
Santander
Time Frame
Start Date:2020-12-10
Completion Date:2024-05-22
Participants
Target number of participants:53
Treatments
Experimental: Guselkumab
Participants will receive guselkumab subcutaneously (SC) every 4 weeks from Week 0 through Wweek 48. This will be in combination with a protocol specified 26-week GC taper. Participants of the long-term extension (LTE) period will continue to receive subcutaneous (SC) injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a Giant cell arteritis (GCA) flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.
Experimental: Placebo
Participants will receive matching placebo SC every 4 weeks from Week 0 through Week 48. This will be in combination with a protocol-specified 26-week GC taper. Participants of the LTE period will continue to receive SC injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a GCA flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.