Trial Outcomes & Findings for A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (NCT NCT01840605)

NCT ID: NCT01840605

Last Updated: 2026-01-08

Results Overview

The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 303 participants
• Primary outcome timeframe: Baseline and 2 weeks
• Results posted on: 2026-01-08

Participant Flow

Participant milestones

Measure	TAU-284 TAU-284 10mg twice daily for 2 weeks	Ketotifen Fumarate Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
Overall Study STARTED	151	152
Overall Study COMPLETED	149	150
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	TAU-284 TAU-284 10mg twice daily for 2 weeks	Ketotifen Fumarate Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
Overall Study Adverse Event	0	1
Overall Study Physician Decision	2	1

Baseline Characteristics

A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis

Baseline characteristics by cohort

Measure	TAU-284 n=151 Participants TAU-284 10mg twice daily for 2 weeks	Ketotifen Fumarate n=152 Participants Ketotifen fumarate dry syrup 1g twice daily for 2 weeks	Total n=303 Participants Total of all reporting groups
Age, Continuous	10.2 years STANDARD_DEVIATION 2.3 • n=18 Participants	10.4 years STANDARD_DEVIATION 2.5 • n=17 Participants	10.3 years STANDARD_DEVIATION 2.4 • n=35 Participants
Sex: Female, Male Female	79 Participants n=18 Participants	62 Participants n=17 Participants	141 Participants n=35 Participants
Sex: Female, Male Male	72 Participants n=18 Participants	90 Participants n=17 Participants	162 Participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline and 2 weeks

The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

Outcome measures

Measure	TAU-284 n=151 Participants TAU-284 10mg twice daily for 2 weeks	Ketotifen Fumarate n=152 Participants Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
Change From Baseline in Pruritus Score	-0.669 units on a scale Standard Error 0.058	-0.638 units on a scale Standard Error 0.058

SECONDARY outcome

Timeframe: Baseline and 1 weeks

The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

Outcome measures

Measure	TAU-284 n=151 Participants TAU-284 10mg twice daily for 2 weeks	Ketotifen Fumarate n=152 Participants Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
Change From Baseline in Pruritus Score	-0.425 units on a scale Standard Error 0.047	-0.510 units on a scale Standard Error 0.047

SECONDARY outcome

Timeframe: Baseline and 2 weeks

Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

Outcome measures

Measure	TAU-284 n=151 Participants TAU-284 10mg twice daily for 2 weeks	Ketotifen Fumarate n=152 Participants Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)	-0.8 units on a scale Standard Error 0.0	-0.7 units on a scale Standard Error 0.0

SECONDARY outcome

Timeframe: Week 2

Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).

Outcome measures

Measure	TAU-284 n=151 Participants TAU-284 10mg twice daily for 2 weeks	Ketotifen Fumarate n=152 Participants Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)	65.6 percentage of participants Interval 57.4 to 73.1	65.1 percentage of participants Interval 57.0 to 72.7

Adverse Events

TAU-284

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Ketotifen Fumarate

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TAU-284 n=151 participants at risk TAU-284 10mg twice daily for 2 weeks	Ketotifen Fumarate n=152 participants at risk Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
Infections and infestations Nasopharyngitis	2.0% 3/151	3.9% 6/152
Nervous system disorders Somnolence	2.0% 3/151	3.9% 6/152

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: cti-inq-ml.JP@ml.tanabe-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER