A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Giant Cell Arteritis

In brief

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).

Key facts

Study ID: NCT04633447
Run by: Janssen Research & Development, LLC
People needed: 53
Starts: 2020-12-10
Expected to finish: 2024-05-22
Last updated by the study team: 2025-07-01

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Has any known severe or uncontrolled GCA complications
Has any rheumatic disease other than GCA such that could interfere with assessment of GCA
Has a current diagnosis or signs or symptoms of severe, progressive, or concomitant medical condition that places the participant at risk by participating in this study)
Has or has had any major ischemic event, within 12 weeks of first study intervention. Has a personal history of arterial thrombosis or venous thromboembolism (including deep venous thrombosis [DVT] and Pulmonary Embolism [PE])
Has any comorbidities requiring 3 or more courses of systemic GCs within 12 months of first study intervention, AND, inability, in the opinion of the investigator, to withdraw GC therapy through protocol-defined taper regimen due to suspected or established adrenal insufficiency, OR, currently on systemic chronic GC therapy for reasons other than GCA and be GC dependent and have the potential to flare due to GC tapering (e.g. unstable asthma, unstable COPD)
Has a history of, or ongoing, chronic or recurrent infectious disease
Has received within specified timeframe, or 5 half-lives (whichever is greater) , or has failed treatment with any investigational or approved biologic agents or Janus Kinase Inhibitor prior to first study intervention
Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start: Any cytotoxic agents (cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents) with 6 months; Hydroxychloroquine, cyclosporine A, azathioprine, tacrolimus, sirolimus, sulfasalazine, leflunomide with cholestyramine washout or mycophenolate mofetil/mycophenolic acid within 3 months; Intramuscular, intra-articular, intrabursal, epidural, intra-lesional or IV GCs within 6 week; and Methotrexate (MTX) within 12 weeks. If started MTX >12 weeks prior to first study intervention MTX must have been at a stable dose for minimally 4 weeks and must not be receiving more than 25 mg oral or SC MTX per week
Has chronic continuous use of systemic GCs for greater than (>) 4 years or inability, in the opinion of the investigator, to withdraw GC treatment through protocol-defined taper regimen due to suspected or established adrenal insufficiency

Where it is running

University of Kansas Medical Center — Kansas City, Kansas, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Cliniques Universitaires St-Luc — Brussels, Belgium
UZ Leuven Gasthuisberg — Leuven, Belgium
Mount Sinai Hospital — Toronto, Ontario, Canada
Hopital du Sacre-Coeur de Montreal — Montreal, Quebec, Canada
CHU Dijon — Dijon, France
Hopital Cochin — Paris, France
Universitatsklinikum Erlangen — Erlangen, Germany
medius KLINIK KIRCHHEIM — Kirchheim unter Teck, Germany
Universitatsklinik Tubingen — Tübingen, Germany
Bnai Zion Medical Center — Haifa, Israel
Hadassah Medical Center — Jerusalem, Israel
Rabin Medical Center Beilinson Campus — Petah Tikva, Israel
Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico — Bolzano, Italy
Ospedale San Raffaele — Milan, Italy
Azienda Ospedaliera di Padova — Padova, Italy
Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
Azienda USL 4 Prato — Prato, Italy
ASUI Santa Maria della Misericordia di Udine — Udine, Italy
Szpital Uniwersytecki Nr 2 w Bydgoszczy — Bydgoszcz, Poland
Szpital Specjalistyczny im. J. Dietla — Krakow, Poland
NZOZ Lecznica MAK MED S C — Nadarzyn, Poland
Hosp Univ A Coruna — A Coruña, Spain

Full record on ClinicalTrials.gov

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