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

NCT03849599 | Completed Phase 1

• 1 other identifier: PRV-300-UC1b
• Study Type: interventional
• Target: 37
• Locations: 3 countries
• Sites: 3

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent adverse events (TEAEs),

  Assessment of safety and tolerability

  12 weeks

Study Arms (2)

PRV-300

EXPERIMENTAL

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

Biological: PRV-300

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive placebo via IV infusion, followed by an 8-week follow-up period.

Biological: Placebo

Interventions

PRV-300 BIOLOGICAL

Treatment

PRV-300

Placebo BIOLOGICAL

Control

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Provention Bio, Inc.: lead

Study Sites (3)

Clinical Site

Tbilisi, Georgia

Location

Clinical Site

Chisinau, Moldova

Location

Clinical Site

Kapitanivka, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Provention Bio, MD

  Provention Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2019
• First Posted: February 21, 2019
• Study Start: February 21, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: February 13, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1); MO (1); GE (1)