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

Crohn's Disease Clinical Trial

— PRINCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03854305
• Other study ID #: PRV-6527-CD2a
• Secondary ID: 2017-003017-25
• Status: Completed
• Phase: Phase 2
• Start date: March 20, 2018
• Est. completion date: August 13, 2019

Study information

• Verified date: September 2021
• Source: Provention Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 13, 2019
• Est. primary completion date: August 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• PRV-6527
Treatment
• Placebo
Comparator

Locations

Country	Name	City	State
Austria	Clinical Site	Innsbruck
Austria	Clinical Site	Klagenfurt am Wörthersee
Austria	Clinical Site	St. Polten
Austria	Clinical Site	St. Veit an der Glan
Austria	Clinical Site	Vienna
Germany	Clinical Site	Berlin
Germany	Clinical Site	Hamburg
Germany	Clinical Site	Kiel
Germany	Clinical Site	Landshut
Germany	Clinical Site	Ulm
Hungary	Clinical Site	Budapest
Hungary	Clinical Site2	Budapest
Hungary	Clinical Site	Miskolc
Hungary	Clinical Site	Mosonmagyaróvár
Poland	Clinical Site	Bydgoszcz
Poland	Clinical Site	Kraków
Poland	Clinical Site2	Kraków
Poland	Clinical Site	Lódz
Poland	Clinical Site	Piotrków Trybunalski
Poland	Clinical Site	Warszawa
Poland	Clinical site	Wroclaw
Poland	Clinical Site2	Wroclaw
Russian Federation	Clinical site	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
Spain	ClinicaL Site	Cordoba
Spain	Clinical Site	Girona
Spain	Clinical Site	Madrid
Spain	Clinical Site 2	Madrid
Ukraine	Clinical Site	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

Sponsors (1)

Lead Sponsor	Collaborator
Provention Bio, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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