A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis

Overview

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.

Full Title of Study: “A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 1, 2019

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

  • Biological: PRV-300
    • Treatment
  • Biological: Placebo
    • Control

Arms, Groups and Cohorts

  • Experimental: PRV-300
    • Subjects in this arm will receive the study drug, PRV-300, via IV infusion, followed by an 8-week follow-up period.
  • Placebo Comparator: Placebo
    • Subjects in this arm will receive placebo via IV infusion, followed by an 8-week follow-up period.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Treatment-emergent adverse events (TEAEs),
    • Time Frame: 12 weeks
    • Assessment of safety and tolerability

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Provention Bio, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Provention Bio, MD, Study Director, Provention Bio

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