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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 September 2021
• Main ID: NCT03854305
• Date of registration: 23/02/2019
• Prospective Registration: No
• Primary sponsor: Provention Bio, Inc.
• Public title: Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease PRINCE
• Scientific title: 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
• Date of first enrolment: March 20, 2018
• Target sample size: 93
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03854305
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Germany, Hungary, Poland, Russian Federation, Spain, Ukraine

Contacts

• Name: Provention Bio, MD
• Affiliation: Provention Bio

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Placebo

Drug: PRV-6527

Primary Outcome(s)

Change from baseline to Week 12 in Crohn's Disease Activity Index score [Time Frame: 12 weeks]

Secondary ID(s)

PRV-6527-CD2a

2017-003017-25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors