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

Crohn's Disease Clinical Trial

Official title:

A Randomized, Open-label, Parallel, Phase 2a Study to Determine the Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155945
• Other study ID #: APD371-004
• Status: Completed
• Phase: Phase 2
• Start date: July 19, 2017
• Est. completion date: September 10, 2018

Study information

• Verified date: October 2021
• Source: Arena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Olorinab
Olorinab active treatment for 8 weeks.

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Hassman Research Institute	Berlin	New Jersey
United States	Clinical Research of Brandon	Brandon	Florida
United States	Northwestern University	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Wake Research Associates	Raleigh	North Carolina
United States	MultiCare Institute for Research and Innovation	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Arena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory - Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Olorinab and Its Metabolites at Week 8	The result for this exploratory endpoint was not reported.	Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose
Other	Exploratory - Median Time for Cmax (Tmax) of Olorinab and Its Metabolites at Week 8	The result for this exploratory endpoint was not reported.	Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose
Other	Exploratory - Mean Area Under the Concentration Time Curve From Time of Dosing to 8 Hours Post-dose (AUC0-8) of Olorinab and Its Metabolites at Week 8	The result for this exploratory endpoint was not reported.	Week 0 (Day 1, Day 2), Week 8 (Day -1), Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose
Other	Exploratory - Mean Change in Abdominal Pain Score (APS) From Trough to Peak at Week 8	The result for this exploratory endpoint was not reported.	Baseline; Week 8
Other	Exploratory - Change From Baseline in Average APS (AAPS)	The result for this exploratory endpoint was not reported.	Baseline; Week 1, 2, 4, 6 and 8
Other	Exploratory - Number of Participants Who Were End-of-treatment Responders	The result for this exploratory endpoint was not reported.	Week 8
Other	Exploratory - Number of Participants Who Were Weekly Responders	The result for this exploratory endpoint was not reported.	Weeks 1, 2, 4, 6, and 8
Other	Exploratory - Number of Pain-free Days Per Week	The result for this exploratory endpoint was not reported.	Week 1, Week 2, Week 4, Week 6, Week 8, and end of treatment
Other	Exploratory - Number of Participants Who Used Pain Rescue Medication	The result for this exploratory endpoint was not reported.	Up to Week 8
Other	Exploratory - Change From Baseline in C-reactive Protein (CRP) Levels at Week 4 and Week 8	The result for this exploratory endpoint was not reported.	Baseline, Week 4, Week 8
Other	Exploratory - Change From Baseline in Fecal Calprotectin Levels at Week 4 and Week 8	The result for this exploratory endpoint was not reported.	Baseline, Week 4, Week 8
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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.	Up to approximately 12 weeks

External Links

•   Safety, Pharmacokinetics, and Efficacy of Olorinab, a Peripherally Acting, Highly Selective, Full Agonist of the Cannabinoid Receptor 2, in a Phase 2a Study of Patients With Chronic Abdominal Pain Associated With Crohn's Disease