A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-Onset or Relapsing Giant Cell Arteritis

Phase 1

• Conditions: Giant Cell Arteritis; MedDRA version: 23.1Level: PTClassification code 10018250Term: Giant cell arteritisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-000622-26-PL
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. Male or female
2. At least 50 years of age, inclusive
3. Diagnosis of GCA according to the revised American College of Rheumatology criteria
4. 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, cranial Magnetic Resonance Imaging 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, CT, PET).
5. Have new onset or relapsing GCA
6. Have active GCA within 6 weeks of first study intervention

Inclusion criterion for LTE period
1. Has completed Week 52 visit of the main study, AND has no signs and symptoms of active GCA, AND completed treatment study intervention according to the protocol, AND completed 26-week protocol defined GCtaper without the need to use rescue medication for GCA, AND has not experienced a GCA flare through Week 52.
2. Has not had any study intervention-related SAE or severe AE
3. Is able and willing to continue (blinded) treatment with study intervention

Please see section 5.1 in the protocol for all inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

1. Has any known severe or uncontrolled GCA complications
2. Has any rheumatic disease other than GCA such as Takayasu's Arteritis, granulomatosis with polyangiitis (Wegener's), RA, systemic
lupus erythematosus that could interfere with assessment of GCA
3. Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal,
endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
4.1a. Has or has had any major ischemic event, within 12 weeks of first study intervention
4.1b. Has a personal history of arterial thrombosis or venous thromboembolism (including deep venous thrombosis [DVT] and Pulmonary Embolism [PE])
5. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of indetermined significance; or
signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
19. Has had a fracture of the hip or leg, major trauma or spinal cord injury, hip or knee replacement within 8 weeks before screening; had
major surgery within 8 weeks before screening, or has not fully recovered from such major surgery, or has such major surgery planned
during the time the participant is expected to participate in the study (48 weeks)
23. Has started Methotrexate (MTX) within 12 weeks of first study intervention. 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

Please see section 5.2 in the protocol for all exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified