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

Provention Bio

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: PRV-6527

Study type: Interventional

Funder types: Industry

Identifiers

NCT03854305

PRV-6527-CD2a

2017-003017-25 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 2 patient groups, including a placebo group

PRV-6527

Experimental group

Description:

Oral administration, 2X daily for 12 weeks

Treatment:

Drug: PRV-6527

Placebo

Placebo Comparator group

Description:

Oral administration, 2X daily for 12 weeks

Treatment:

Drug: Placebo