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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03155945
• Date of registration: 11/05/2017
• Prospective Registration: Yes
• Primary sponsor: Arena Pharmaceuticals
• Public title: Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal Pain
• Scientific 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
• Date of first enrolment: May 18, 2017
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03155945
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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 SES-CD
score of < 10 or FCP < 500 mcg/g within 4 weeks before Screening.

- Moderate to severe abdominal pain as defined by 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 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Abdominal Pain

Crohn's Disease

Intervention(s)

Drug: APD371

Primary Outcome(s)

Number of patients with adverse events and abnormal clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis). [Time Frame: up to 8 weeks]

Secondary Outcome(s)

Change in area under the plasma concentration versus time curve (AUC) [Time Frame: up to 8 weeks]

Frequency of pain rescue medication use in each treatment cohort [Time Frame: up to 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]

Change in abdominal pain score (APS) [Time Frame: up to 8 weeks]

Change in average APS (AAPS) [Time Frame: up to 8 weeks]

Proportion of subjects who are weekly responders [Time Frame: up tp 8 weeks]

Effect of APD371 treatment on reduction in fecal calprotectin levels at week 4 and week 8 [Time Frame: up to 8 weeks]

Proportion of subjects who are end-of-treatment responders [Time Frame: up to 8 weeks]

Change in peak plasma concentration (Cmax) [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]

Change in time to Cmax (Tmax) [Time Frame: up to 8 weeks]

Secondary ID(s)

APD371-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors