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

NCT04633447 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR108887CNTO1959GCA20012020-000622-26
• Study Type: interventional
• Target: 53
• Locations: 9 countries
• Sites: 30

Brief 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).

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (1)

• Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28

  GC free remission at Week 28 was defined as (1) no signs or symptoms of active Giant cell arteritis (GCA) at Week 28; (2) absence of GCA flare from first dose of the study drug through Week 28; and (3) adherence to the protocol specified 26-week GC taper regimen. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA.

  Week 28

Secondary Outcomes (14)

• Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52

  Weeks 28, 32, 36, 40, 44, 48 and 52

• Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52

  Weeks 28, 32, 36, 40, 44, 48 and 52

• Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52

  Weeks 28, 32, 36, 40, 44, 48 and 52

• Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52

  Weeks 28, 32, 36, 40, 44, 48 and 52

• Main Study: Cumulative Glucocorticoid (GC) Dose

  Baseline (Day 1) up to Weeks 28 and 52

Study Arms (2)

Guselkumab

EXPERIMENTAL

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.

Drug: Guselkumab

Placebo

EXPERIMENTAL

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.

Drug: Placebo

Interventions

Guselkumab DRUG

Guselkumab will be administered subcutaneously.

Also known as: Tremfya, CNTO 1959

Guselkumab

Placebo DRUG

Matching placebo will be administered subcutaneously.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (30)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

CHU Dijon

Dijon, 21000, France

Location

Hopital Cochin

Paris, 75014, France

Location

Universitatsklinikum Erlangen

Erlangen, 91054, Germany

Location

medius KLINIK KIRCHHEIM

Kirchheim unter Teck, 73230, Germany

Location

Universitatsklinik Tubingen

Tübingen, 72076, Germany

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Rabin Medical Center Beilinson Campus

Petah Tikva, 49100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico

Bolzano, 39100, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35121, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda USL 4 Prato

Prato, 59100, Italy

Location

ASUI Santa Maria della Misericordia di Udine

Udine, 33100, Italy

Location

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, 85 168, Poland

Location

Szpital Specjalistyczny im. J. Dietla

Krakow, 31-121, Poland

Location

NZOZ Lecznica MAK MED S C

Nadarzyn, 05 830, Poland

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29009, Spain

Location

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Location

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Manager Clinical Science Translational
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 18, 2020
• Study Start: December 10, 2020
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (6); DE (3); BE (2); FR (2); IT (6); US (2); CA (2); PL (3); IL (4)