Trial Outcomes & Findings for Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease (NCT NCT00573469)

NCT ID: NCT00573469

Last Updated: 2012-07-12

Results Overview

Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 75 participants
• Primary outcome timeframe: Baseline to 8 weeks
• Results posted on: 2012-07-12

Participant Flow

First participant enrolled on 16 October 2006. Last participant completed on 4 March 2008. Out of 90 screened participants, 77 participants (target was 75) were enrolled and included in Full Analysis set and safety analysis set. The numbers of participants in each set were 26 in D9421-C 9 mg, 25 in D9421-C 15 mg and 26 in Placebo, respectively.

Patients who had a CDAI score of less than 200 were excluded before randomisation.

Participant milestones

Measure	D9421-C 9 mg An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg An enteric capsule including D9421-C 15 mg was given once daily.	Placebo An enteric capsule without D9421-C was given once daily.
Overall Study STARTED	26	25	26
Overall Study COMPLETED	20	21	22
Overall Study NOT COMPLETED	6	4	4

Reasons for withdrawal

Measure	D9421-C 9 mg An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg An enteric capsule including D9421-C 15 mg was given once daily.	Placebo An enteric capsule without D9421-C was given once daily.
Overall Study Adverse Event	1	1	1
Overall Study Withdrawal by Subject	0	2	0
Overall Study Other	5	1	3

Baseline Characteristics

Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

Baseline characteristics by cohort

Measure	D9421-C 9 mg n=26 Participants An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg n=25 Participants An enteric capsule including D9421-C 15 mg was given once daily.	Placebo n=26 Participants An enteric capsule without D9421-C was given once daily.	Total n=77 Participants Total of all reporting groups
Age, Customized <30 years	8 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	19.0 Participants n=4 Participants
Age, Customized >=30 years	18 Participants n=5 Participants	18 Participants n=7 Participants	22 Participants n=5 Participants	58.0 Participants n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	22.0 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	55.0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.

Outcome measures

Measure	D9421-C 9 mg n=26 Participants An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg n=25 Participants An enteric capsule including D9421-C 15 mg was given once daily.	Placebo n=26 Participants An enteric capsule without D9421-C was given once daily.
Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment	6 Participants	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline to 2 weeks

The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.

Outcome measures

Measure	D9421-C 9 mg n=26 Participants An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg n=25 Participants An enteric capsule including D9421-C 15 mg was given once daily.	Placebo n=26 Participants An enteric capsule without D9421-C was given once daily.
Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment	2 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to 4 weeks

The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.

Outcome measures

Measure	D9421-C 9 mg n=26 Participants An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg n=25 Participants An enteric capsule including D9421-C 15 mg was given once daily.	Placebo n=26 Participants An enteric capsule without D9421-C was given once daily.
Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment	5 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: At 8 weeks

Time from randomisation to the remission of Crohn's disease defined as CDAI score  150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained.

Outcome measures

Measure	D9421-C 9 mg n=26 Participants An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg n=25 Participants An enteric capsule including D9421-C 15 mg was given once daily.	Placebo n=26 Participants An enteric capsule without D9421-C was given once daily.
Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method	38.5 Percentage of participants 77.7	36.0 Percentage of participants 84.7	19.0 Percentage of participants 89.9

SECONDARY outcome

Timeframe: Baseline to 8 weeks

CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured.

Outcome measures

Measure	D9421-C 9 mg n=26 Participants An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg n=25 Participants An enteric capsule including D9421-C 15 mg was given once daily.	Placebo n=26 Participants An enteric capsule without D9421-C was given once daily.
Change in CDAI Score From Baseline to 8 Weeks	-48 Score on a scale Standard Deviation 77.5	-58 Score on a scale Standard Deviation 84.7	-27 Score on a scale Standard Deviation 89.9

Adverse Events

D9421-C 9 mg

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

D9421-C 15 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	D9421-C 9 mg n=26 participants at risk An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg n=25 participants at risk An enteric capsule including D9421-C 15 mg was given once daily.	Placebo n=26 participants at risk An enteric capsule without D9421-C was given once daily.
Gastrointestinal disorders Crohn's Disease	3.8% 1/26	0.00% 0/25	3.8% 1/26
Gastrointestinal disorders Ileus	3.8% 1/26	0.00% 0/25	0.00% 0/26
Infections and infestations Perianal abscess	0.00% 0/26	0.00% 0/25	3.8% 1/26

Other adverse events

Measure	D9421-C 9 mg n=26 participants at risk An enteric capsule including D9421-C 9 mg was given once daily.	D9421-C 15 mg n=25 participants at risk An enteric capsule including D9421-C 15 mg was given once daily.	Placebo n=26 participants at risk An enteric capsule without D9421-C was given once daily.
Skin and subcutaneous tissue disorders Acne	0.00% 0/26	12.0% 3/25	0.00% 0/26
Blood and lymphatic system disorders Anaemia	15.4% 4/26	0.00% 0/25	0.00% 0/26
Gastrointestinal disorders Constipation	7.7% 2/26	0.00% 0/25	0.00% 0/26
Respiratory, thoracic and mediastinal disorders Cough	7.7% 2/26	0.00% 0/25	0.00% 0/26
Gastrointestinal disorders Crohn's Disease	15.4% 4/26	0.00% 0/25	0.00% 0/26
Infections and infestations Nasopharyngitis	23.1% 6/26	0.00% 0/25	7.7% 2/26
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	0.00% 0/26	8.0% 2/25	0.00% 0/26
Skin and subcutaneous tissue disorders Rash	0.00% 0/26	12.0% 3/25	0.00% 0/26
Gastrointestinal disorders Vomiting	0.00% 0/26	0.00% 0/25	7.7% 2/26
Gastrointestinal disorders Nausea	0.00% 0/26	0.00% 0/25	7.7% 2/26

Additional Information

Gerard Lynch

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
• Publication restrictions are in place

Restriction type: OTHER