Status:
COMPLETED
A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Provention Bio, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis. Subjects will receive either PRV-300 or placebo treatment. Eac...
Detailed Description
This is a Phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo sc...
Eligibility Criteria
Inclusion
- Subject must be a man or woman aged 18-75 years, inclusive.
- Subject has a clinical diagnosis of UC at least 3 months before screening.
- Subject has moderately to severely active UC, defined as a Mayo score of 6 to 12, inclusive, at screening.
- Subject has a Mayo endoscopic subscore of ≥2 based on central read of the video sigmoidoscopy at screening.
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Exclusion
- Subject has severe extensive colitis as evidenced by any of the following:
- Current hospitalization for the treatment of UC.
- Investigator judgment that the subject is likely to require a colectomy within 12 weeks of baseline.
- Temperature ≥37.8 ºC (oral or tympanic) and a heart rate \>90 bpm.
- Subject has UC limited to \<15 cm of the colon.
- Subject has a diagnosis of CD or the presence or history of fistula or indeterminate colitis.
- Presence of a gastrostomy, jejunostomy, ileostomy or colostomy.
- Subject has had or is expected to have surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions that may confound study evaluations from 2 months before screening through the end of this study.
- Presence of symptomatic colonic or small bowel obstruction
- History of colonic resection
- History of colonic mucosal high-grade dysplasia
- Subject has chronic or recurrent infectious disease
- Subject has positive serology to human immunodeficiency virus (HIV) 1 or 2, hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening.
- Subject has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening).
- Subject has ever received PRV-300 (or CNTO 3157) or has known allergies, hypersensitivity, or intolerance to PRV-300 or its excipients; or known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, to monoclonal antibodies or antibody fragments; or a history of severe allergic reactions, angioedema, or anaphylaxis that might suggest risk for a reaction to a biologic agent.
- Subject 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 :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03849599
Start Date
February 21 2018
End Date
March 1 2019
Last Update
February 13 2020
Active Locations (3)
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1
Clinical Site
Tbilisi, Georgia
2
Clinical Site
Chisinau, Moldova
3
Clinical Site
Kapitanivka, Ukraine