Phase 3
N=112
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01514240 ↗Enrolled (actual)
112
Serious AEs
3.6%
Results posted
Oct 2016
Primary outcome: Primary: Remission After 8-week of Treatment — 17; 14 Participants — p=0.526
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- D9421-C capsule 3 mg (Drug); Mesalazine tablets (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission After 8-week of Treatment |
17; 14 | 0.526 |
| SECONDARY Remission After 2-week of Treatment |
7; 6 | 0.768 |
| SECONDARY Remission After 4-week of Treatment |
12; 7 | 0.208 |
| SECONDARY Change in Observed CDAI Scores From Baseline to Weeks 2 |
-38.5; -15.7 | 0.058 |
| SECONDARY Change in Observed CDAI Scores From Baseline to Weeks 4 |
-58.7; -28.7 | 0.014 sig |
| SECONDARY Change in Observed CDAI Scores From Baseline to Weeks 8 |
-67.0; -45.7 | 0.144 |
| SECONDARY Cumulative Remission Rate at Week 2 |
12.5; 10.7 | — |
| SECONDARY Cumulative Remission Rate at Week 4 |
25.0; 17.9 | — |
| SECONDARY Cumulative Remission Rate at Week 8 |
37.5; 30.4 | — |
| SECONDARY Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2 |
19; 11 | — |
| SECONDARY Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4 |
22; 13 | — |
| SECONDARY Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8 |
27; 18 | — |
| SECONDARY Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2 |
14; 10 | — |
| SECONDARY Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4 |
19; 11 | — |
| SECONDARY Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8 |
24; 17 | — |
| SECONDARY Change in Total IBDQ Scores From Baseline to Weeks 2 |
16.2; 5.7 | — |
| SECONDARY Change in Total IBDQ Scores From Baseline to Weeks 4 |
19.4; 6.8 | — |
| SECONDARY Change in Total IBDQ Scores From Baseline to Weeks 8 |
18.3; 5.8 | — |
| SECONDARY Change in Total IBDQ Scores From Baseline to Weeks 10 |
21.1; 7.1 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function |
6.1; 2.7 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function |
6.6; 2.8 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function |
6.5; 2.4 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function |
6.9; 3.6 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom |
3.0; 1.0 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom |
3.3; 1.3 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom |
3.5; 1.2 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom |
3.8; 1.2 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function |
5.1; 1.3 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function |
7.0; 2.1 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function |
5.9; 1.6 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function |
8.0; 1.3 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 2 - Social Function |
1.9; 0.6 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 4 - Social Function |
2.5; 0.7 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 8 - Social Function |
2.3; 0.7 | — |
| SECONDARY Change in IBDQ Scores From Baseline to Weeks 10 - Social Function |
2.4; 1.2 | — |
Summary
The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤ 150.
Eligibility Criteria
Inclusion Criteria
- 15 years of age or older
- Main active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation until the study completion or discontinuation
- Ability to read, write and to fill a diary card and HRQL questionnaire Having mild to moderate active Crohn's disease, defined as CDAI score of 180-400 at baseline
Exclusion Criteria
- Patient with CD lesion or status which may affect the evaluation of the efficacy (e.g. lesion only in the upper G-I, active anorectal lesion, abscess formation, stenosis, fistulae, ostomy, short bowel or other uncontrolled concomitant disease)
- Patient who need any concomitant treatment for CD that may affect the assessment for efficacy of the study drug
- Patient who need any medication which is prohibited due to suspected influence to metabolism of the study drug
- Patient who is judged to be inadequate to participate in this study from the safety point of view Patient with well-founded doubt about protocol violation
Data sourced from ClinicalTrials.gov (NCT01514240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.