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

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ClinicalTrials.gov Identifier: NCT03155945
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : May 24, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Abdominal Pain Drug: APD371 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Number of patients with adverse events and abnormal clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis). [ Time Frame: up to 8 weeks ]
    Tolerability and safety of two doses of APD371 in subjects with Crohn's Disease experiencing abdominal pain

Secondary Outcome Measures :
  1. Change in peak plasma concentration (Cmax) [ Time Frame: up to 8 weeks ]
  2. Change in time to Cmax (Tmax) [ Time Frame: up to 8 weeks ]
  3. Change in area under the plasma concentration versus time curve (AUC) [ Time Frame: up to 8 weeks ]
  4. 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

  5. Change in average APS (AAPS) [ Time Frame: up to 8 weeks ]
    From Screening and averaged weekly to week 8

  6. Proportion of subjects who are end-of-treatment responders [ Time Frame: up to 8 weeks ]
  7. Proportion of subjects who are weekly responders [ Time Frame: up tp 8 weeks ]
  8. Number of pain-free days per week in each treatment cohort, based on responses to the APS [ Time Frame: up to 8 weeks ]
  9. Frequency of pain rescue medication use in each treatment cohort [ Time Frame: up to 8 weeks ]
  10. Effect of APD371 treatment on reduction in C-reactive protein (CRP) levels at week 4 and week 8 [ Time Frame: up to 8 weeks ]
  11. Effect of APD371 treatment on reduction in fecal calprotectin levels at week 4 and week 8 [ Time Frame: up to 8 weeks ]

Eligibility Criteria

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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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155945

Contact: Chad Orevillo, MPH +1 8584537200 corevillo@arenapharm.com

United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
Contact: Michael Hassman, MD         
Sponsors and Collaborators
Arena Pharmaceuticals
More Information

Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03155945     History of Changes
Other Study ID Numbers: APD371-004
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Abdominal Pain
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive