- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633447
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis (THEIA)
March 26, 2024 updated by: Janssen Research & Development, LLC
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
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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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).
Participants who complete the Week 52 visit and are assessed to be in glucocorticoid (GC)-free remission, may have the option to participate in the long-term extension (LTE) period of the study for up to 12 months.
This study will evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of 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 for the main study and for participants that continue in the LTE period, the total study duration will be up to 112 weeks.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Contact
- Phone Number: 844-434-4210
- Email: Participate-In-This-Study@its.jnj.com
Study Locations
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Brussel, Belgium, 1200
- Cliniques Universitaires St-Luc
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Leuven, Belgium, 3000
- UZ Leuven Gasthuisberg
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Ontario
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Toronto, Ontario, Canada, M5T 3L9
- Mount Sinai Hospital
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Quebec
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Montreal, Quebec, Canada, H4J 1C5
- Hopital du Sacre-Coeur de Montreal
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Dijon, France, 21000
- CHU Dijon
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Paris, France, 75014
- Hôpital Cochin
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Erlangen, Germany, 91054
- Universitätsklinikum Erlangen
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Kirchheim unter Teck, Germany, 73230
- medius KLINIK KIRCHHEIM
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Tubingen, Germany, 72076
- Universitatsklinik Tubingen
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Hifa, Israel, 31048
- Bnai Zion Medical Center
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Jerusalem, Israel, 91120
- Hadassah Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center Beilinson Campus
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Bolzano, Italy, 39100
- Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico
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Milan, Italy, 20132
- Ospedale San Raffaele
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Padova, Italy, 35121
- Azienda Ospedaliera di Padova
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Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Prato, Italy, 59100
- Azienda USL 4 Prato
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Udine, Italy, 33100
- ASUI Santa Maria della Misericordia di Udine
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Bydgoszcz, Poland, 85-168
- Szpital Uniwersytecki Nr 2 w Bydgoszczy
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Krakow, Poland, 31-121
- Szpital Specjalistyczny im. J. Dietla
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Nadarzyn, Poland, 05 830
- NZOZ Lecznica MAK MED S C
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A Coruna, Spain, 15006
- Hosp. Univ. A Coruna
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Barcelona, Spain, 08036
- Hosp. Clinic de Barcelona
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Madrid, Spain, 28040
- Hosp. Clinico San Carlos
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Madrid, Spain, 28041
- Hosp. Univ. 12 de Octubre
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Málaga, Spain, 29009
- Hosp. Regional Univ. de Malaga
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Santander, Spain, 39008
- Hosp. Univ. Marques de Valdecilla
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 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
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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Guselkumab will be administered subcutaneously.
Other Names:
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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.
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Matching placebo will be administered subcutaneously.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission
Time Frame: At Week 28
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Percentage of participants achieving GC-free remission will be assessed.
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At Week 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving GC-Free Remission
Time Frame: From Week 28 up to Week 52
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Percentage of participants achieving GC-free remission will be assessed.
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From Week 28 up to Week 52
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Percentage of Participants Achieving GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR)
Time Frame: At Week 28 and up to Week 52
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Percentage of participants achieving GC-free remission and normalization of ESR will be assessed using the Westergren method.
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At Week 28 and up to Week 52
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Percentage of Participants Achieving GC-Free Remission and Normalization of C-Reactive Protein (CRP)
Time Frame: At Week 28 and up to Week 52
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Percentage of participants achieving GC-free remission and normalization of CRP will be assessed.
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At Week 28 and up to Week 52
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Percentage of Participants Achieving GC-Free Remission and Normalization of Both ESR and CRP
Time Frame: At Week 28 and up to Week 52
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Percentage of participants achieving normalization of both ESR and CRP will be assessed.
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At Week 28 and up to Week 52
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Cumulative GC dose
Time Frame: Through Week 28 up to Week 52
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Cumulative GC dose will be assessed.
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Through Week 28 up to Week 52
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Time to First GCA Disease Flare or Discontinuation of Study Intervention due to AE of Worsening of GCA
Time Frame: Through Week 28 up to Week 52
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The time to first GCA disease flare or discontinuation of study intervention due to AE of worsening of GCA will be assessed.
Flare is defined as the recurrence of signs and symptoms of GCA, with or without elevation of inflammatory markers, and the necessity for an increase in GC dose for GCA.
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Through Week 28 up to Week 52
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Number of GCA Disease Flares or Discontinuation of Study Intervention due to AE of Worsening of GCA
Time Frame: Through Week 28 up to Week 52
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Number of GCA disease flares or discontinuation of study intervention due to AE of worsening of GCA will be assessed.
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Through Week 28 up to Week 52
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Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 60
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An adverse event (AE) occurring at or after the initial administration of study intervention through the day of last dose plus 12 weeks (up to Week 60) is considered to be treatment emergent.
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
An adverse event does not necessarily have a causal relationship with the intervention and can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
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Up to Week 60
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Number of Participants with TEAEs by System Organ Class With a Frequency Threshold of 5 percent (%) or More
Time Frame: Up to Week 60
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An AE occurring at or after the initial administration of study intervention through the day of last dose plus 12 weeks is considered to be treatment emergent.
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
An adverse event does not necessarily have a causal relationship with the intervention and can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
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Up to Week 60
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Number of Participants with Treatment Emergent Serious Adverse Event (SAEs)
Time Frame: Up to Week 60
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SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
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Up to Week 60
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Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time Frame: Up to Week 60
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Number of participants with clinically significant abnormalities in vital signs (Temperature, pulse/heart rate, respiratory rate and blood pressure) will be assessed.
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Up to Week 60
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Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Time Frame: Up to Week 60
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Number of participants with clinically significant abnormalities in laboratory parameters (blood chemistry, hematology, coagulation, serology) will be assessed.
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Up to Week 60
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Serum Concentrations of Guselkumab
Time Frame: Up to Week 52
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Serum concentrations of guselkumab will be assessed in participants receiving active study intervention.
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Up to Week 52
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Number of Participants with Antibodies to Guselkumab
Time Frame: Up to Week 60
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Number of participants with antibodies to guselkumab will be assessed in participants receiving active study intervention.
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Up to Week 60
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2020
Primary Completion (Estimated)
June 25, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
November 6, 2020
First Submitted That Met QC Criteria
November 17, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Vasculitis
- Skin Diseases, Vascular
- Vasculitis, Central Nervous System
- Polymyalgia Rheumatica
- Giant Cell Arteritis
- Arteritis
Other Study ID Numbers
- CR108887
- 2020-000622-26 (EudraCT Number)
- CNTO1959GCA2001 (Other Identifier: Janssen Research & Development, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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