Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: PRV-6527; Drug: Placebo

• Registration Number: NCT03854305
• Lead Sponsor: Provention Bio, Inc.

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 males and females aged 18-75 years with moderately to severely active CD for at least 3 months. Each subject will receive the assigned treatment over 12 weeks, followed by a 4-week safety follow-up period.

Study Timeline

• Study Start: 2018-03-20
• Study First Submitted: 2019-02-23
• Study First Submitted QC: 2019-02-23
• Study First Posted: 2019-02-26
• Primary Completion: 2019-08-13
• Study Completion: 2019-08-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

1. Subject must be a man or woman between 18 years and 75 (inclusive) years of age.
2. Has moderate to severe CD and a histologic diagnosis of CD for at least 3 months before screening.

Exclusion Criteria

1. Has other gastrointestinal inflammatory diseases.
2. 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.
3. 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.
4. 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.
5. Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRV-6527	PRV-6527	Oral administration, 2X daily for 12 weeks
Placebo	Placebo	Oral administration, 2X daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline to Week 12 in Crohn's Disease Activity Index score	12 weeks	Crohn's Disease Activity Scale will be assessed by collecting information on 8 different Crohn's Disease-related variables : extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stood, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variable are based on dairy of patient for 7 days Scale range is 0 to 600 with 0 being the best oputcome and a score of 600, the worst outcome.

Trial Locations

Locations (7)

Clinical site; 🇺🇦 Khmelnytskyi, Ukraine

Clinical Site2; 🇺🇦 Zaporizhzhya, Ukraine

Clinical Site 3; 🇺🇦 Kyiv, Ukraine

Clinical Site; 🇺🇦 Zaporizhzhya, Ukraine

Clinical Site3; 🇺🇦 Zaporizhzhya, Ukraine

Clinical Site 2; 🇪🇸 Madrid, Spain

ClinicaL Site; 🇪🇸 Cordoba, Spain