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

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ClinicalTrials.gov Identifier: NCT04633447
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: Guselkumab Drug: Placebo Phase 2

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). 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : August 28, 2023
Estimated Study Completion Date : October 10, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Guselkumab

Arm Intervention/treatment
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.
Drug: Guselkumab
Guselkumab Dose 1 and Dose 2 will be administered IV and SC.
Other Names:
  • Tremfya
  • CNTO 1959

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.
Drug: Placebo
Matching placebo will be administered IV and SC.




Primary Outcome Measures :
  1. Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission [ Time Frame: At Week 28 ]
    Percentage of participants achieving GC-free remission will be assessed.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving GC-Free Remission [ Time Frame: From Week 28 up to Week 52 ]
    Percentage of participants achieving GC-free remission will be assessed.

  2. Percentage of Participants Achieving GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) [ Time Frame: At Week 28 and up to Week 52 ]
    Percentage of participants achieving GC-free remission and normalization of ESR will be assessed using the Westergren method.

  3. Percentage of Participants Achieving GC-Free Remission and Normalization of C-Reactive Protein (CRP) [ Time Frame: At Week 28 and up to Week 52 ]
    Percentage of participants achieving GC-free remission and normalization of CRP will be assessed.

  4. Percentage of Participants Achieving GC-Free Remission and Normalization of Both ESR and CRP [ Time Frame: At Week 28 and up to Week 52 ]
    Percentage of participants achieving normalization of both ESR and CRP will be assessed.

  5. Cumulative GC dose [ Time Frame: Through Week 28 up to Week 52 ]
    Cumulative GC dose will be assessed.

  6. Time to First GCA Disease Flare [ Time Frame: Up to Week 52 ]
    The time to first GCA disease flare 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.

  7. Number of GCA Disease Flares [ Time Frame: Up to Week 52 ]
    Number of GCA disease flares will be assessed.

  8. Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 60 ]
    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.

  9. Number of Participants with TEAEs by System Organ Class With a Frequency Threshold of 5 percent (%) or More [ Time Frame: Up to Week 60 ]
    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.

  10. Number of Participants with Treatment Emergent Serious Adverse Event (SAEs) [ Time Frame: Up to Week 60 ]
    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.

  11. Number of Participants with Clinically Significant Abnormalities in Vital Signs [ Time Frame: Up to Week 60 ]
    Number of participants with clinically significant abnormalities in vital signs (Temperature, pulse/heart rate, respiratory rate and blood pressure) will be assessed.

  12. Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters [ Time Frame: Up to Week 60 ]
    Number of participants with clinically significant abnormalities in laboratory parameters (blood chemistry, hematology, coagulation, serology) will be assessed.

  13. Serum Concentrations of Guselkumab [ Time Frame: Up to Week 52 ]
    Serum concentrations of guselkumab will be assessed in participants receiving active study intervention.

  14. Number of Participants with Antibodies to Guselkumab [ Time Frame: Up to Week 60 ]
    Number of participants with antibodies to guselkumab will be assessed in participants receiving active study intervention.

  15. Change From Baseline in CRP Level [ Time Frame: Baseline and Up to Week 52 ]
    Change from baseline in CRP will be assessed.

  16. Change From Baseline in ESR [ Time Frame: Baseline and Up to Week 52 ]
    Change from baseline in ESR will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633447


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04633447    
Other Study ID Numbers: CR108887
2020-000622-26 ( EudraCT Number )
CNTO1959GCA2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases