Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis
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. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.
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 score. Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period. The total duration of the study will be 20 weeks, excluding the screening period. The primary objective is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active UC. The secondary objectives are to evaluate the effect of PRV-300 for 12 weeks in subjects with active UC on: * Pharmacodynamics: Changes in gene scores in colonic biopsies over the course of treatment. * Pharmacokinetics: Peak (Cmax) and trough (Cmin) serum concentrations of PRV-300 in subjects with active UC. * Immunogenicity: Immunogenicity of PRV-300 in subjects with active UC * Endoscopic: Trends in endoscopic disease activity in subjects with active UC.
Interventions
BIOLOGICALPRV-300
Treatment
BIOLOGICALPlacebo
Control
Sponsors
Provention Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject must be a man or woman aged 18-75 years, inclusive. 2. Subject has a clinical diagnosis of UC at least 3 months before screening. 3. Subject has moderately to severely active UC, defined as a Mayo score of 6 to 12, inclusive, at screening. 4. Subject has a Mayo endoscopic subscore of ≥2 based on central read of the video sigmoidoscopy at screening. 5. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Exclusion criteria
1. Subject has severe extensive colitis as evidenced by any of the following: 1. Current hospitalization for the treatment of UC. 2. Investigator judgment that the subject is likely to require a colectomy within 12 weeks of baseline. 3. Temperature ≥37.8 ºC (oral or tympanic) and a heart rate \>90 bpm. 2. Subject has UC limited to \<15 cm of the colon. 3. Subject has a diagnosis of CD or the presence or history of fistula or indeterminate colitis. 4. Presence of a gastrostomy, jejunostomy, ileostomy or colostomy. 5. 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. 6. Presence of symptomatic colonic or small bowel obstruction 7. History of colonic resection 8. History of colonic mucosal high-grade dysplasia 9. Subject has chronic or recurrent infectious disease 10. Subject has positive serology to human immunodeficiency virus (HIV) 1 or 2, hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening. 11. 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). 12. 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. 13. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-emergent adverse events (TEAEs), | 12 weeks | Assessment of safety and tolerability |
Countries
Georgia, Moldova, Ukraine
Outcome results
None listed