Back to resultsTolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain
Primary Purpose
Crohn's Disease, Abdominal Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Olorinab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility 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.
Sites / Locations
- Clinical Research of Brandon
- Northwestern University
- University of Michigan Medical Center
- Hassman Research Institute
- Wake Research Associates
- University of Cincinnati Medical Center
- MultiCare Institute for Research and Innovation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Olorinab 25 mg TID
Olorinab 100 mg TID
Arm Description
Participants received olorinab 25 milligrams (mg) tablet by mouth, three times daily (TID) for 8 weeks
Participants received olorinab 100 mg oral tablets TID for 8 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03155945
Brief Title
Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
September 10, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arena Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Abdominal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olorinab 25 mg TID
Arm Type
Experimental
Arm Description
Participants received olorinab 25 milligrams (mg) tablet by mouth, three times daily (TID) for 8 weeks
Arm Title
Olorinab 100 mg TID
Arm Type
Experimental
Arm Description
Participants received olorinab 100 mg oral tablets TID for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Olorinab
Other Intervention Name(s)
APD371
Intervention Description
Olorinab active treatment for 8 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to approximately 12 weeks
Other Pre-specified Outcome Measures:
Title
Exploratory - Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Olorinab and Its Metabolites at Week 8
Description
The result for this exploratory endpoint was not reported.
Time Frame
Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose
Title
Exploratory - Median Time for Cmax (Tmax) of Olorinab and Its Metabolites at Week 8
Description
The result for this exploratory endpoint was not reported.
Time Frame
Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose
Title
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
Description
The result for this exploratory endpoint was not reported.
Time Frame
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
Title
Exploratory - Mean Change in Abdominal Pain Score (APS) From Trough to Peak at Week 8
Description
The result for this exploratory endpoint was not reported.
Time Frame
Baseline; Week 8
Title
Exploratory - Change From Baseline in Average APS (AAPS)
Description
The result for this exploratory endpoint was not reported.
Time Frame
Baseline; Week 1, 2, 4, 6 and 8
Title
Exploratory - Number of Participants Who Were End-of-treatment Responders
Description
The result for this exploratory endpoint was not reported.
Time Frame
Week 8
Title
Exploratory - Number of Participants Who Were Weekly Responders
Description
The result for this exploratory endpoint was not reported.
Time Frame
Weeks 1, 2, 4, 6, and 8
Title
Exploratory - Number of Pain-free Days Per Week
Description
The result for this exploratory endpoint was not reported.
Time Frame
Week 1, Week 2, Week 4, Week 6, Week 8, and end of treatment
Title
Exploratory - Number of Participants Who Used Pain Rescue Medication
Description
The result for this exploratory endpoint was not reported.
Time Frame
Up to Week 8
Title
Exploratory - Change From Baseline in C-reactive Protein (CRP) Levels at Week 4 and Week 8
Description
The result for this exploratory endpoint was not reported.
Time Frame
Baseline, Week 4, Week 8
Title
Exploratory - Change From Baseline in Fecal Calprotectin Levels at Week 4 and Week 8
Description
The result for this exploratory endpoint was not reported.
Time Frame
Baseline, Week 4, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arena CT.gov Administrator
Organizational Affiliation
Arena Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research of Brandon
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
MultiCare Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33863856
Citation
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.
Results Reference
derived
Links:
URL
https://academic.oup.com/crohnscolitis360/article/3/1/otaa089/5937224
Description
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
Learn more about this trial
Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain
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