Last updated: March 14, 2024
Sponsor: EHL Bio Co., Ltd.
Overall Status: Active - Not Recruiting
Phase
2
Condition
Atopic Dermatitis
Allergy
Dermatitis, Atopic
Treatment
Placebo
ADSTEM Inj.
Clinical Study ID
NCT04137562
AD-CP-18-1
30902
Ages 19-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 6months
- Patients with moderate to severe atopic dermatitis who meet all of the followingcriteria
- SCORAD score ≥ 20points
- EASI score ≥ 12points
- BSA ≥ 10%
- Patients with inadequate response to the stable use of topical atopic dermatitistreatment within 24 weeks prior to study initiation, or those who are unable toadminister topical atopic dermatitis treatment due to safety reasons
- Patients who voluntarily agreed in writing to participate in this clinical trial
Exclusion
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 priorto administration of the clinical trial drug to visit 6 such as Immune functionmodifier(tacrolimus, pimecrolimus, cyclosporine, etc.), and high-frequency topicalsteroids in Groups 1 to 5, systemic steroids, systemic photochemotherapy, medicationthat are thought to affect other immune functions (such as immunoglobulin therapy likedupilumab, tralloquinap and desensitization therapy, etc.)
- Women who are pregnant, breastfeeding or have a pregnancy plan up to visit 6 or who donot use available contraceptive methods (women of childbearing age must be negative inscreening pregnancy test)
- If patients are the male subject, Those who do not agree to have a contraceptionduring the clinical trial (If the male subject or female partner is infertile, theabove-mentioned contravention method is unnecessary)
- Patients participating in other clinical trials or participating in other clinicaltrials within the last 30 days
- Patients who have experienced significant adverse events during treatment with stemcell 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 usedin the manufacture of medicines for clinical trials
- Patients with renal dysfunction whose creatinine level is more than twice the normalupper 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 otherexaminers
Study Design
Total Participants: 118
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 11, 2019
Estimated Completion Date:
October 31, 2027
Study Description
Connect with a study center
Chungnam National University Hospital
Daejeon, Chungcheongnam-do
Korea, Republic ofSite Not Available
Korea University AnSan Hospital
Ansan, Gyeonggi-do
Korea, Republic ofSite Not Available
Chung-Ang University Hospital
Seoul, Seoulteukbyeolsi
Korea, Republic ofSite Not Available
Kyunghee University Medical Center
Seoul, Seoulteukbyeolsi
Korea, Republic ofSite Not Available
SMG-SNU Boramae Medical Center
Seoul, Seoulteukbyeolsi
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Seoulteukbyeolsi
Korea, Republic ofSite Not Available

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