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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria.

  • - 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; or evidence of cranial GCA by doppler-ultrasound; or cranial Magnetic Resonance Imaging or Magnetic Resonance Angiography; or other imaging modality upon agreement with the sponsor.
  • - 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.
Exclusion criteria.
  • - 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 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 6 weeks and must not be receiving more than 20 mg oral MTX (or 15 mg SC) 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04633447
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Canada, France, Germany, Israel, Italy, Poland, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Giant Cell Arteritis
Study Website: View Trial Website
Additional Details

Giant cell arteritis (GCA) is a non-necrotizing granulomatous systemic vasculitis of unknown etiology affecting medium-sized and large arteries usually accompanied or preceded by systemic inflammation. Guselkumab is a monoclonal antibody (mAb) that binds to the p19 sub-unit of human interleukin (IL)-23 with high affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent activation and cytokine production. It is used in treatment of psoriatic arthritis, generalized pustular psoriasis, erythrodermic psoriasis. The study consists of a screening period (less than or equal to (<=) 6 weeks), double-blind treatment period (48 weeks), and safety follow-up period (12 weeks). This study will evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of intravenous (IV) and subcutaneous (SC) administered guselkumab in combination with a 26-week GC taper regimen for the treatment of active new-onset or relapsing GCA in adult participants. The total duration of the study is up to 66 weeks.

Arms & Interventions

Arms

Experimental: Guselkumab

Participants will receive guselkumab dose 1 intravenously (IV) at week 0, 4, and 8 and guselkumab dose 2 subcutaneously (SC) every 4 weeks (q4w) from week 12 through week 48. This will be in combination with a protocol specified 26-week GC taper.

Experimental: Placebo

Participants will receive matching placebo IV at week 0, 4 and 8 and matching placebo SC q4 weeks from week 12 through week 48. This will be in combination with a protocol-specified 26-week GC taper.

Interventions

Drug: - Guselkumab

Guselkumab Dose 1 and Dose 2 will be administered IV and SC.

Drug: - Placebo

Matching placebo will be administered IV and SC.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NIH Clinical Center, Bethesda, Maryland

Status

Not yet recruiting

Address

NIH Clinical Center

Bethesda, Maryland, 20892

Massachusetts General Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Hospital for Special Surgery, New York, New York

Status

Not yet recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

International Sites

Cliniques Universitaires St-Luc, Brussel, Belgium

Status

Not yet recruiting

Address

Cliniques Universitaires St-Luc

Brussel, , 1200

UZ Leuven Gasthuisberg, Leuven, Belgium

Status

Not yet recruiting

Address

UZ Leuven Gasthuisberg

Leuven, , 3000

Mount Sinai Hospital, Toronto, Ontario, Canada

Status

Not yet recruiting

Address

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9

Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada

Status

Not yet recruiting

Address

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5

Brest, France

Status

Withdrawn

Address

CHU de Brest - Hôpital de la Cavale Blanche

Brest, , 29200

CHU caen, Caen, France

Status

Withdrawn

Address

CHU caen

Caen, , 14033

CHU Dijon, Dijon, France

Status

Not yet recruiting

Address

CHU Dijon

Dijon, , 21000

Hopital Cochin, Paris, France

Status

Recruiting

Address

Hopital Cochin

Paris, , 75014

Universitätsklinikum Erlangen, Erlangen, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Erlangen

Erlangen, , 91054

Medizinische Hochschule Hannover, Hannover, Germany

Status

Not yet recruiting

Address

Medizinische Hochschule Hannover

Hannover, , 30625

medius KLINIK KIRCHHEIM, Kirchheim unter Teck, Germany

Status

Not yet recruiting

Address

medius KLINIK KIRCHHEIM

Kirchheim unter Teck, , 73230

Universitätsklinik Tübingen, Tübingen, Germany

Status

Not yet recruiting

Address

Universitätsklinik Tübingen

Tübingen, , 72076

Bnai Zion Medical Center, Hifa, Israel

Status

Not yet recruiting

Address

Bnai Zion Medical Center

Hifa, , 31048

Hadassah Medical Center, Jerusalem, Israel

Status

Not yet recruiting

Address

Hadassah Medical Center

Jerusalem, , 91120

Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel

Status

Not yet recruiting

Address

Rabin Medical Center, Beilinson Campus

Petah Tikva, , 49100

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Status

Not yet recruiting

Address

Tel Aviv Sourasky Medical Center

Tel Aviv, , 64239

Brunico - Bolzano, Italy

Status

Not yet recruiting

Address

Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico

Brunico - Bolzano, , 39031

Ospedale San Raffaele, Milan, Italy

Status

Not yet recruiting

Address

Ospedale San Raffaele

Milan, , 20132

Azienda Ospedaliera di Padova, Padova, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera di Padova

Padova, , 35121

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Status

Not yet recruiting

Address

Fondazione IRCCS Policlinico San Matteo

Pavia, , 27100

Azienda USL 4 Prato, Prato, Italy

Status

Not yet recruiting

Address

Azienda USL 4 Prato

Prato, , 59100

Udine, Italy

Status

Not yet recruiting

Address

ASUI Santa Maria della Misericordia di Udine

Udine, , 33100

Szpital Uniwersytecki Nr 2 w Bydgoszczy, Bydgoszcz, Poland

Status

Recruiting

Address

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, , 85-168

Szpital Specjalistyczny im. J. Dietla, Krakow, Poland

Status

Recruiting

Address

Szpital Specjalistyczny im. J. Dietla

Krakow, , 31-121

Hosp. Univ. A Coruña, A Coruña, Spain

Status

Not yet recruiting

Address

Hosp. Univ. A Coruña

A Coruña, , 15006

Hosp. Clinic I Provincial de Barcelona, Barcelona, Spain

Status

Not yet recruiting

Address

Hosp. Clinic I Provincial de Barcelona

Barcelona, , 08036

Hosp. Clinico San Carlos, Madrid, Spain

Status

Not yet recruiting

Address

Hosp. Clinico San Carlos

Madrid, , 28040

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

Hosp. Regional Univ. de Malaga, Málaga, Spain

Status

Recruiting

Address

Hosp. Regional Univ. de Malaga

Málaga, , 29009