Clinical trial NCT04087863: Administration for Placebo Group and Evalution the Safety and Efficacy in Atopic Dermatitis Patients
Official title: A Multi-center, Open, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis Who Participated in a Placebo Group in K0102 Clinical Trial: 2nd Extension Study of K0102
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 99
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate to Severe Atopic Dermatitis

Brief summary: A Multi-center, Open, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of FURESTEM-AD inj. in Patients with Moderate to Severe Chronic Atopic Dermatitis Who Participated in a Placebo Group in K0102 Clinical Trial: 2nd Extension Study of K0102


Eligibility criteria: Inclusion Criteria:

1. Subject who enrolled K0102 Clinical Trial(parent study) and be assigned to a placebo group
2. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects with medical history or surgery/procedure history
2. Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)
3. Pregnant, breast-feeding women or women who plan to become pregnant during six months after administering the clinical trial medication
4. Subjects who participate in other clinical trial or participated in other clinical trial within 4 weeks
5. In case follow-up is not possible to end of this study period
6. Any other condition which the investigator judges would make patient unsuitable for study participation

Primary outcomes:
measure: Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)
timeFrame: 3 years
measure: Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at each visit (EASI-50)
timeFrame: 3 years
measure: Rate of change in EASI from baseline
timeFrame: 3 years
measure: Change in EASI from baseline
timeFrame: 3 years
measure: Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
timeFrame: 3 years
measure: Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
timeFrame: 3 years
measure: Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
timeFrame: 3 years
measure: Rate of change in SCORAD index from baseline at each visit
timeFrame: 3 years
measure: Change in SCORAD index from baseline at each visit
timeFrame: 3 years
measure: Rate of change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit
timeFrame: 3 years
measure: Change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit
timeFrame: 3 years
measure: Change in total serum Immunoglobulin E(IgE) from baseline
timeFrame: 3 years
measure: Rate of change in total serum Immunoglobulin E(IgE) from baseline
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
References: