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


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Verified May 2017 by Arena Pharmaceuticals

Sponsor:

Information provided by (Responsible Party):

Arena Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03155945

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.

Crohn’s Disease
Abdominal Pain
Drug: APD371 Phase 2

Study Type: Interventional
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

Primary Outcome Measures:

Secondary Outcome Measures:

  • 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 ]

Estimated Enrollment: 20
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03155945

Arena site no 2
Berlin, New Jersey, United States, 08009

Arena Pharmaceuticals

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:

Crohn Disease
Abdominal Pain
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on May 16, 2017