Dermatitis, Atopic
Conditions
Brief summary
The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.
Detailed description
This is a randomized, double-blind, parallel-group comparative study to demonstrate the noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis, as assessed by the primary endpoint of the change from baseline in pruritus score after 2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to investigate the safety, and plasma concentrations of TAU-284.
Interventions
Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 7 and 15 years * Patients giving assent and whose legal guardian giving informed consent * Outpatients * Patients diagnosed as atopic dermatitis * Patients who require the treatment with topical corticosteroid on areas other than face, head and neck * Patients whose diaries can be properly maintained * Patients who have 2 grades or more pruritus score
Exclusion criteria
* Patients with bronchial asthma who require concomitant use of the corticosteroid * Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy * Patients with current or previous history of drug hypersensitivity * Patients who have been treated with Bepotastine besilate in the past * Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied * Patients who have spastic disease such as epilepsy * Patients who concurrently have renal function abnormalities that may cause safety problems * Patients who do not give consent to use birth control * Pregnant patients, at risk of pregnancy or breastfeeding * Patients who had participated in any clinical trial in the last 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pruritus Score | Baseline and 2 weeks | The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pruritus Score | Baseline and 1 weeks | The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe). |
| Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline) | Baseline and 2 weeks | Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe). |
| Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus) | 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). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAU-284 TAU-284 10mg twice daily for 2 weeks | 151 |
| Ketotifen Fumarate Ketotifen fumarate dry syrup 1g twice daily for 2 weeks | 152 |
| Total | 303 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Physician Decision | 2 | 1 |
Baseline characteristics
| Characteristic | TAU-284 | Ketotifen Fumarate | Total |
|---|---|---|---|
| Age, Continuous | 10.2 years STANDARD_DEVIATION 2.3 | 10.4 years STANDARD_DEVIATION 2.5 | 10.3 years STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 79 Participants | 62 Participants | 141 Participants |
| Sex: Female, Male Male | 72 Participants | 90 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 151 | 11 / 152 |
| serious Total, serious adverse events | 0 / 151 | 0 / 152 |
Outcome results
Primary
Change From Baseline in Pruritus Score
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TAU-284 | Change From Baseline in Pruritus Score | -0.669 units on a scale | Standard Error 0.058 |
| Ketotifen Fumarate | Change From Baseline in Pruritus Score | -0.638 units on a scale | Standard Error 0.058 |
Secondary
Change From Baseline in Pruritus Score
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Time frame: Baseline and 1 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TAU-284 | Change From Baseline in Pruritus Score | -0.425 units on a scale | Standard Error 0.047 |
| Ketotifen Fumarate | Change From Baseline in Pruritus Score | -0.510 units on a scale | Standard Error 0.047 |
Secondary
Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)
Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).
Time frame: Week 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAU-284 | Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus) | 65.6 percentage of participants |
| Ketotifen Fumarate | Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus) | 65.1 percentage of participants |
Secondary
Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)
Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TAU-284 | Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline) | -0.8 units on a scale | Standard Error 0 |
| Ketotifen Fumarate | Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline) | -0.7 units on a scale | Standard Error 0 |