Verified May 2017 by Arena Pharmaceuticals
Information provided by (Responsible Party):
First received: May 11, 2017
Last updated: May 15, 2017
Last verified: May 2017
The purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of APD371 in subjects with Crohn’s disease experiencing abdominal pain.
|Drug: APD371||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-label, Parallel, Phase 2a Study to Determine the Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn’s Disease Experiencing Abdominal Pain|
- Change in peak plasma concentration (Cmax) [ Time Frame: up to 8 weeks ]
- Change in time to Cmax (Tmax) [ Time Frame: up to 8 weeks ]
- Change in area under the plasma concentration versus time curve (AUC) [ Time Frame: up to 8 weeks ]
- Change in abdominal pain score (APS) [ Time Frame: up to 8 weeks ]
From pre-dose (trough) to 1.5 hr post-dose (peak) following the first of 3 daily doses of APD371; assessed daily to Day 56
- Change in average APS (AAPS) [ Time Frame: up to 8 weeks ]
From Screening and averaged weekly to week 8
- Proportion of subjects who are end-of-treatment responders [ Time Frame: up to 8 weeks ]
- Proportion of subjects who are weekly responders [ Time Frame: up tp 8 weeks ]
- Number of pain-free days per week in each treatment cohort, based on responses to the APS [ Time Frame: up to 8 weeks ]
- Frequency of pain rescue medication use in each treatment cohort [ Time Frame: up to 8 weeks ]
- Effect of APD371 treatment on reduction in C-reactive protein (CRP) levels at week 4 and week 8 [ Time Frame: up to 8 weeks ]
- Effect of APD371 treatment on reduction in fecal calprotectin levels at week 4 and week 8 [ Time Frame: up to 8 weeks ]
|Anticipated Study Start Date:||May 2017|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
|Experimental: APD371 low dose treatment||Drug: APD371
APD371 active treatment for 8 weeks.
|Experimental: APD371 high dose treatment||Drug: APD371
APD371 active treatment for 8 weeks.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Senior)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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 SES-CD score of < 6 or ileal SES-CD < 4 or FCP < 300 mcg/g at screening.
- Moderate to severe abdominal pain as defined by AAPS of >5 points 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 subjects 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03155945
|Arena site no 2|
|Berlin, New Jersey, United States, 08009|
|Responsible Party:||Arena Pharmaceuticals|
|ClinicalTrials.gov Identifier:||NCT03155945 History of Changes|
|Other Study ID Numbers:||APD371-004|
|Study First Received:||May 11, 2017|
|Last Updated:||May 15, 2017|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Digestive System Diseases
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
ClinicalTrials.gov processed this record on May 16, 2017