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

Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn's

This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Placebo; Drug: PRV-6527

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 Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Clinical Site
  • Klagenfurt am Wörthersee, Austria
    • Clinical Site
  • St. Polten, Austria
    • Clinical Site
  • St. Veit an der Glan, Austria
    • Clinical Site
  • Vienna, Austria
    • Clinical Site
• Germany
  • Berlin, Germany
    • Clinical Site
  • Hamburg, Germany
    • Clinical Site
  • Kiel, Germany
    • Clinical Site
  • Landshut, Germany
    • Clinical Site
  • Ulm, Germany
    • Clinical Site
• Hungary
  • Budapest, Hungary
    • Clinical Site2
  • Budapest, Hungary
    • Clinical Site
  • Miskolc, Hungary
    • Clinical Site
  • Mosonmagyaróvár, Hungary
    • Clinical Site
• Poland
  • Bydgoszcz, Poland
    • Clinical Site
  • Kraków, Poland
    • Clinical Site2
  • Kraków, Poland
    • Clinical Site
  • Piotrków Trybunalski, Poland
    • Clinical Site
  • Warszawa, Poland
    • Clinical Site
  • Wrocław, Poland
    • Clinical Site2
  • Wrocław, Poland
    • Clinical Site
  • Łódź, Poland
    • Clinical Site
• Russian Federation
  • Kemerovo, Russian Federation
    • Clinical Site
  • Krasnoyarsk, Russian Federation
    • Clinical Site
  • Moscow, Russian Federation
    • Clinical Site2
  • Moscow, Russian Federation
    • Clinical Site
  • Penza, Russian Federation
    • Clinical Site
  • Rostov-on-Don, Russian Federation
    • Clinical Site
  • Saint Petersburg, Russian Federation
    • Clinical Site
  • Samara, Russian Federation
    • Clinical Site2
  • Samara, Russian Federation
    • Clinical Site
  • Tomsk, Russian Federation
    • Clinical Site
• Spain
  • Cordoba, Spain
    • Clinical Site
  • Girona, Spain
    • Clinical Site
  • Madrid, Spain
    • Clinical Site 2
  • Madrid, Spain
    • Clinical Site
• Ukraine
  • Kharkiv, Ukraine
    • Clinical Site
  • Khmelnytskyi, Ukraine
    • Clinical Site
  • Kyiv, Ukraine
    • Clinical Site 3
  • Kyiv, Ukraine
    • Clinical Site2
  • Kyiv, Ukraine
    • Clinical Site
  • Lviv, Ukraine
    • Clinical Site2
  • Lviv, Ukraine
    • Clinical Site
  • Odesa, Ukraine
    • Clinical Site
  • Ternopil', Ukraine
    • Clinical Site
  • Vinnytsia, Ukraine
    • Clinical Site2
  • Vinnytsia, Ukraine
    • Clinical Site3
  • Vinnytsia, Ukraine
    • Clinical Site
  • Zaporizhzhya, Ukraine
    • Clinical Site2
  • Zaporizhzhya, Ukraine
    • Clinical Site3
  • Zaporizhzhya, Ukraine
    • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRV-6527; Oral administration, 2X daily for 12 weeks	Drug: PRV-6527; Treatment
Placebo Comparator: Placebo; Oral administration, 2X daily for 12 weeks	Drug: Placebo; Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to Week 12 in Crohn's Disease Activity Index score	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.	12 weeks

Collaborators and Investigators

• Sponsor: Provention Bio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): August 13, 2019
• Study Completion (Actual): August 13, 2019

Study Registration Dates

• First Submitted: February 23, 2019
• First Submitted That Met QC Criteria: February 23, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Crohn's Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: PRV-6527-CD2a; 2017-003017-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No