Clinical trial NCT03854305: Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: Provention Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-26
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline to Week 12 in Crohn's Disease Activity Index score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Clinical Site
city: Klagenfurt am Wörthersee
country: Austria
facility: Clinical Site
city: St. Polten
country: Austria
facility: Clinical Site
city: St. Veit an der Glan
country: Austria
facility: Clinical Site
city: Vienna
country: Austria
facility: Clinical Site
city: Berlin
country: Germany
facility: Clinical Site
city: Hamburg
country: Germany
facility: Clinical Site
city: Kiel
country: Germany
facility: Clinical Site
city: Landshut
country: Germany
facility: Clinical Site
city: Ulm
country: Germany
facility: Clinical Site
city: Budapest
country: Hungary
facility: Clinical Site2
city: Budapest
country: Hungary
facility: Clinical Site
city: Miskolc
country: Hungary
facility: Clinical Site
city: Mosonmagyaróvár
country: Hungary
facility: Clinical Site
city: Bydgoszcz
country: Poland
facility: Clinical Site
city: Kraków
country: Poland
facility: Clinical Site2
city: Kraków
country: Poland
facility: Clinical Site
city: Piotrków Trybunalski
country: Poland
facility: Clinical Site
city: Warszawa
country: Poland
facility: Clinical Site
city: Wrocław
country: Poland
facility: Clinical Site2
city: Wrocław
country: Poland
facility: Clinical site
city: Łódź
country: Poland
facility: Clinical Site
city: Kemerovo
country: Russian Federation
facility: Clinical site
city: Krasnoyarsk
country: Russian Federation
facility: Clinical Site
city: Moscow
country: Russian Federation
facility: Clinical Site2
city: Moscow
country: Russian Federation
facility: Clinical Site
city: Penza
country: Russian Federation
facility: Clinical Site
city: Rostov-on-Don
country: Russian Federation
facility: Clinical site
city: Saint Petersburg
country: Russian Federation
facility: Clinical Site
city: Samara
country: Russian Federation
facility: Clinical Site2
city: Samara
country: Russian Federation
facility: Clinical Site
city: Tomsk
country: Russian Federation
facility: Clinical Site
city: Cordoba
country: Spain
facility: ClinicaL Site
city: Girona
country: Spain
facility: Clinical Site
city: Madrid
country: Spain
facility: Clinical Site 2
city: Madrid
country: Spain
facility: Clinical Site
city: Kharkiv
country: Ukraine
facility: Clinical Site
city: Khmelnytskyi
country: Ukraine
facility: Clinical site
city: Kyiv
country: Ukraine
facility: Clinical Site 3
city: Kyiv
country: Ukraine
facility: Clinical Site2
city: Kyiv
country: Ukraine
facility: Clinical Site
city: Lviv
country: Ukraine
facility: Clinical Site2
city: Lviv
country: Ukraine
facility: Clinical Site
city: Odesa
country: Ukraine
facility: Clinical Site
city: Ternopil'
country: Ukraine
facility: Clinical Site
city: Vinnytsia
country: Ukraine
facility: Clinical Site2
city: Vinnytsia
country: Ukraine
facility: Clinical Site3
city: Vinnytsia
country: Ukraine
facility: Clinical Site
city: Zaporizhzhya
country: Ukraine
facility: Clinical Site2
city: Zaporizhzhya
country: Ukraine
facility: Clinical Site3
city: Zaporizhzhya
country: Ukraine
facility: Clinical Site
Study officials:
affiliation: Provention Bio
name: Provention Bio, MD
role: STUDY_DIRECTOR
References: