Clinical trial NCT04137562: Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
Official title: A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Adipose Derived Mesenchymal Stem cell
ADMSC
AD
Inflammatory disease
ADMC
Stem cell
ehlbio
Lead sponsor: EHL Bio Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-24
Enrollment: 118
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis.

The aim of this study is to evaluate the safety and efficacy of ADSTEM Inj. against Placebo in the treatment of atopic dermatitis in patients with moderate to severe acute and chronic atopic.

Detailed description: This clinical trial is designed with multi-organization, random assignment, single-blind, second-phase clinical trials and open long-term follow up studies, and is intended for patients with secondary or above subacuteal and chronic atopic dermatitis. If the test subjects voluntarily agree in writing to participate in this clinical trial, they shall conduct the examination and examination required for four weeks prior to administration of the investigational product (visit 1) in accordance with the clinical trial plan. As a result of the suitability assessment of the test subjects, those who comply with the inclusion/exclusion criteria, adipose tissue will be collected through the liposuction method and randomly assigned to each arms. Subjects who are eligible for administration of the investigational product on the day of administration (visit 2) under the investigator's judgment are given intravenous administration of the clinical trial medication once at the date of administration (visit 2, visit 3) and follow-up inspection is conducted at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after the first administration of the investigational product and safety and efficacy assessments are conducted for a total of 16 weeks. The test subjects assigned to the placebo group shall be compensated by administering a experimental drug on demand after the visit 6. It is a principle to administer the test drug prepared from the previously obtained adipose tissue, and it is possible to carry out further adipose tissue collection if necessary. However, no safety and efficacy assessments of compensatory treatments will be collected. Safety and efficacy will be analyzed after all the subjects has completed visit 6. For the experimental group only, long-term observation study for safety assessment is conducted at the point of 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months after the second administration of the investigational product for a total of 5 years.

Eligibility criteria: Inclusion Criteria:

* At the time of visit 1, only men and women aged between 19 and 70
* Patients with atopic dermatitis meeting the Hanifin and Rajka diagnostic criteria
* Subacute and chronic patients with symptoms of atopic dermatitis lasting at least 6 months
* Patients with moderate to severe atopic dermatitis who meet all of the following criteria

  1. SCORAD score ≥ 20points
  2. EASI score ≥ 12points
  3. BSA ≥ 10%
* Patients with inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks prior to study initiation, or those who are unable to administer topical atopic dermatitis treatment due to safety reasons
* Patients who voluntarily agreed in writing to participate in this clinical trial

Exclusion Criteria:

* Patients with systemic infection symptoms at the time of clinical trials
* Patients with HIV, HBV, HCV, Syphilis test positive
* Patients with uncontrolled asthma disease at the time of clinical trial participation
* Patients who were considered inevitable to receive the medication from 1 month prior to administration of the clinical trial drug to visit 6 such as Immune function modifier(tacrolimus, pimecrolimus, cyclosporine, etc.), and high-frequency topical steroids in Groups 1 to 5, systemic steroids, systemic photochemotherapy, medication that are thought to affect other immune functions (such as immunoglobulin therapy like dupilumab, tralloquinap and desensitization therapy, etc.)
* Women who are pregnant, breastfeeding or have a pregnancy plan up to visit 6 or who do not use available contraceptive methods (women of childbearing age must be negative in screening pregnancy test)
* If patients are the male subject, Those who do not agree to have a contraception during the clinical trial (If the male subject or female partner is infertile, the above-mentioned contravention method is unnecessary)
* Patients participating in other clinical trials or participating in other clinical trials within the last 30 days
* Patients who have experienced significant adverse events during treatment with stem cell therapies
* Patients with stem cell therapy doses or history of participating in clinical trials
* Patients with a history of hypersensitivity to antibiotics and antifungal agents used in the manufacture of medicines for clinical trials
* Patients with renal dysfunction whose creatinine level is more than twice the normal upper limit in the screening test
* Patients with hepatic dysfunction whose AST (Aspartate Amino Transaminase) and ALT (Alanine Amino Transaminase) levels are more than three times the normal upper limit
* Patients who are not suitable for this clinical trial under the judgment of the other examiners

Primary outcomes:
measure: EASI-50
timeFrame: 16 weeks
Secondary outcomes:
measure: EASI-50
timeFrame: 4, 8, 12 weeks
measure: EASI-75
timeFrame: 4, 8, 12, 16 weeks
measure: EASI score
timeFrame: 4, 8, 12, 16 weeks
measure: SCORAD-50
timeFrame: 4, 8, 12, 16 weeks
measure: SCORAD-75
timeFrame: 4, 8, 12, 16 weeks
measure: SCORAD score
timeFrame: 4, 8, 12, 16 weeks
measure: SCORAD subgroup
timeFrame: 4, 8, 12, 16 weeks
measure: Severity
timeFrame: 4, 8, 12, 16 weeks
measure: IGA grade
timeFrame: 4, 8, 12, 16 weeks
measure: IGA -1 or more grade
timeFrame: 4, 8, 12, 16 weeks
measure: IGA -2 or more grade
timeFrame: 4, 8, 12, 16 weeks
measure: Total IgE
timeFrame: 4, 8, 12, 16 weeks
measure: PGE2 and ECP
timeFrame: 4, 8, 12, 16 weeks
measure: Immune cytokine
timeFrame: 4, 8, 12, 16 weeks
measure: Remedy used days and frequency
timeFrame: 4, 8, 12, 16 weeks
measure: Remedy used subjects
timeFrame: 4, 8, 12, 16 weeks
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Chungcheongnam-do
city: Ansan
country: Korea, Republic of
facility: Korea University AnSan Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
state: Seoulteukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
state: Seoulteukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoulteukbyeolsi
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
state: Seoulteukbyeolsi
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Seongjun Seo, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Ansan Hospital
name: Sanguk Son, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Soyeon Jo, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital
name: Young-joon Seo, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Donghun Lee, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University Medical Center
name: Mingyeong Shin, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: