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

Phase 1

Conditions: MedDRA version: 23.1Level: PTClassification code 10018250Term: Giant cell arteritisSystem Organ Class: 10047065 - Vascular disorders
Giant Cell Arteritis
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2020-000622-26-IT

Lead Sponsor: JANSSEN CILAG INTERNATIONAL NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Male or female (according to their reproductive organs and functions assigned by chromosomal complement)
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 OR, Evidence of cranial GCA by doppler-ultrasound, cranial Magnetic Resonance Imaging or Magnetic Resonance Angiography
5. Have new onset or relapsing GCA
6. Have active GCA within 6 weeks of first 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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

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, PMR, 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. Has or has had any major ischemic event, within 12 weeks of first study intervention
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

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