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

• Status: Completed
• Trial end date: 2018-09-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arena Pharmaceuticals

Criteria

Key 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).

Key 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.

Note: other protocol defined Inclusion/Exclusion criteria may apply.