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

Phase 2

Completed

• Conditions: Crohn's Disease; Abdominal Pain
• Interventions: Drug: Olorinab

• Registration Number: NCT03155945
• Lead Sponsor: Arena Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-16
• Study Start: 2017-07-19
• Primary Completion: 2018-09-10
• Study Completion: 2018-09-10
• Disposition First Submitted: 2019-09-04
• Results First Submitted: 2021-09-03
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-05
• Disposition First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Results First Posted: 2021-11-02
• Disposition First Posted: 2021-11-02
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olorinab 25 mg TID	Olorinab	Participants received olorinab 25 milligrams (mg) tablet by mouth, three times daily (TID) for 8 weeks
Olorinab 100 mg TID	Olorinab	Participants received olorinab 100 mg oral tablets TID for 8 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to approximately 12 weeks	TEAE was defined as an adverse event (AE) that occurred after first dose of olorinab. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events. Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

Trial Locations

Locations (7)

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

Clinical Research of Brandon; 🇺🇸 Brandon, Florida, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

MultiCare Institute for Research and Innovation; 🇺🇸 Tacoma, Washington, United States

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States