Status:
COMPLETED
Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Provention Bio, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease
Detailed Description
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active Crohn's disease. Eligible subjects include mal...
Eligibility Criteria
Inclusion
- Subject must be a man or woman between 18 years and 75 (inclusive) years of age.
- Has moderate to severe CD and a histologic diagnosis of CD for at least 3 months before screening.
Exclusion
- Has other gastrointestinal inflammatory diseases.
- Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence.
- Has colon cancer or severe dysplasia. Subjects with CD for ≥8 years involving the colon are not excluded if they had a colonoscopy to assess for the presence of dysplasia within 1 year before baseline or if they had a colonoscopy at the screening visit that excludes any evidence of malignancy.
- Has current signs or symptoms of an acute infection or infected skin wounds or ulcers, with the exception of nonserious infections in the opinion of the Investigator (e.g. sepsis, pneumonia, or pyelonephritis), including any infection requiring hospitalization or IV antibiotics, within 8 weeks before baseline.
- Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- Has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2019
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03854305
Start Date
March 20 2018
End Date
August 13 2019
Last Update
September 16 2021
Active Locations (51)
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1
Clinical Site
Innsbruck, Austria
2
Clinical Site
Klagenfurt, Austria
3
Clinical Site
Sankt Pölten, Austria
4
Clinical Site
Sankt Veit an der Glan, Austria