Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain

NCT ID: NCT03155945

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-19
• Study Completion Date: 2018-09-10

Brief Summary

The purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease experiencing abdominal pain.

Conditions

Crohn's Disease; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Olorinab 25 mg TID

Participants received olorinab 25 milligrams (mg) tablet by mouth, three times daily (TID) for 8 weeks

Group Type: EXPERIMENTAL

Olorinab

Intervention Type: DRUG

Olorinab active treatment for 8 weeks.

Olorinab 100 mg TID

Participants received olorinab 100 mg oral tablets TID for 8 weeks

Group Type: EXPERIMENTAL

Olorinab

Intervention Type: DRUG

Olorinab active treatment for 8 weeks.

Interventions

Olorinab

Olorinab active treatment for 8 weeks.

Intervention Type: DRUG

Other Intervention Names

APD371

Eligibility Criteria

Inclusion Criteria

• A clinical diagnosis of Crohn's disease for at least 3 months prior to screening corroborated by prior endoscopic and histopathologic documentation consistent with Crohn's disease.
• Quiescent to mildly active inflammatory Crohn's disease defined with a total of simple endoscopy score for Crohn's disease (SES-CD) score of < 10 or fecal calprotectin < 500 mcg/g within 4 weeks before Screening.
• Moderate to severe abdominal pain as defined by average abdominal pain score (AAPS) of >/= 4points on 7 consecutive days of the screening period up to Day -2. AAPS will be based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst possible abdominal pain).

Exclusion Criteria

• Female participants who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 prior to study drug administration.
• Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial infarction, unstable angina.
• Other significant chronic pain conditions that in the opinion of the Investigator may influence the abdominal pain score.
• History of extensive colonic resection, subtotal or total colectomy.
• History of >3 small bowel resections or diagnosis of short bowel syndrome or who have undergone bowel resection within 6 months prior to randomization.
• Chronic active hepatitis B within the last year (unless shown at the time of study entry to be hepatitis B antigen negative) or any history of hepatitis C.
• Evidence of current gastro-intestinal infection (bacterial or parasitic) or significant infection within 45 days of screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arena Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arena CT.gov Administrator

Role: STUDY_DIRECTOR

Arena Pharmaceuticals

Locations

Clinical Research of Brandon

Brandon, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Hassman Research Institute

Berlin, New Jersey, United States

Wake Research Associates

Raleigh, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

MultiCare Institute for Research and Innovation

Tacoma, Washington, United States

Countries

United States

References

Castro J, Garcia-Caraballo S, Maddern J, Schober G, Lumsden A, Harrington A, Schmiel S, Lindstrom B, Adams J, Brierley SM. Olorinab (APD371), a peripherally acting, highly selective, full agonist of the cannabinoid receptor 2, reduces colitis-induced acute and chronic visceral hypersensitivity in rodents. Pain. 2022 Jan 1;163(1):e72-e86. doi: 10.1097/j.pain.0000000000002314.

Reference Type: DERIVED

PMID: 33863856 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

APD371-004

Identifier Type: -

Identifier Source: org_study_id