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
2 other identifiers
interventional
93
7 countries
51
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2018
Shorter than P25 for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2018
CompletedFirst Submitted
Initial submission to the registry
February 23, 2019
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2019
CompletedSeptember 16, 2021
September 1, 2021
1.4 years
February 23, 2019
September 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
PRV-6527
EXPERIMENTALOral administration, 2X daily for 12 weeks
Placebo
PLACEBO COMPARATOROral administration, 2X daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Subject must be a man or woman between 18 years and 75 (inclusive) years of age.
- Has moderate to severe CD and a histologic diagnosis of CD for at least 3 months before screening.
You may not qualify if:
- Has other gastrointestinal inflammatory diseases.
- 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.
- 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.
- 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.
- Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Clinical Site
Innsbruck, Austria
Clinical Site
Klagenfurt, Austria
Clinical Site
Sankt Pölten, Austria
Clinical Site
Sankt Veit an der Glan, Austria
Clinical Site
Vienna, Austria
Clinical Site
Berlin, Germany
Clinical Site
Hamburg, Germany
Clinical Site
Kiel, Germany
Clinical Site
Landshut, Germany
Clinical Site
Ulm, Germany
Clinical Site2
Budapest, Hungary
Clinical Site
Budapest, Hungary
Clinical Site
Miskolc, Hungary
Clinical Site
Mosonmagyaróvár, Hungary
Clinical Site
Bydgoszcz, Poland
Clinical Site2
Krakow, Poland
Clinical Site
Krakow, Poland
Clinical Site
Lodz, Poland
Clinical Site
Piotrkow Trybunalski, Poland
Clinical Site
Warsaw, Poland
Clinical Site2
Wroclaw, Poland
Clinical site
Wroclaw, Poland
Clinical site
Kemerovo, Russia
Clinical Site
Krasnoyarsk, Russia
Clinical Site2
Moscow, Russia
Clinical Site
Moscow, Russia
Clinical Site
Penza, Russia
Clinical site
Rostov-on-Don, Russia
Clinical Site
Saint Petersburg, Russia
Clinical Site2
Samara, Russia
Clinical Site
Samara, Russia
Clinical Site
Tomsk, Russia
ClinicaL Site
Córdoba, Spain
Clinical Site
Girona, Spain
Clinical Site 2
Madrid, Spain
Clinical Site
Madrid, Spain
Clinical Site
Kharkiv, Ukraine
Clinical site
Khmelnytskyi, Ukraine
Clinical Site 3
Kyiv, Ukraine
Clinical Site2
Kyiv, Ukraine
Clinical Site
Kyiv, Ukraine
Clinical Site2
Lviv, Ukraine
Clinical Site
Lviv, Ukraine
Clinical Site
Odesa, Ukraine
Clinical Site
Ternopil, Ukraine
Clinical Site2
Vinnytsia, Ukraine
Clinical Site3
Vinnytsia, Ukraine
Clinical Site
Vinnytsia, Ukraine
Clinical Site2
Zaporizhzhya, Ukraine
Clinical Site3
Zaporizhzhya, Ukraine
Clinical Site
Zaporizhzhya, Ukraine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Provention Bio, MD
Provention Bio
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2019
First Posted
February 26, 2019
Study Start
March 20, 2018
Primary Completion
August 13, 2019
Study Completion
August 13, 2019
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share