Safety and Efficacy of SCM-AGH in Subjects With Moderate to Severe Atopic Dermatitis
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0004806
- Lead Sponsor
- SCM Lifescience
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 92
1)Subjects who are males or females aged ? 19 years
2)Subjects who are diagnosed as AD based on the Eichenfield revised criteria of Hannifin and Rajka that
a.has been present for at least 1 year before the Screening visit, and
b.have chronic AD symptoms continually for at least 6 months before Screening visit, and
c.Prior screening visit, inadequate response to existing standard of treatment (topical medications of atopic dermatitis) within 6 months or topical treatment is medically not recommended (e.g., intolerance, important side effect or due to stability risks) and no other stem cell treatment has been administered.
Note:
a.inability to achieve good disease control defined as mild disease or better (e.g., IGA =2) after use of at least a moderate potency TCS for at least 28 days, or for the maximum duration recommended by the product prescribing information (e.g., 14 days for super-potent TCS), whichever is shorter.
b.Patients who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate, and corticosteroids will also be considered as a surrogate for having inadequate response to topical therapy.
3)Subjects who have moderate to severe AD (EASI =16) at the Screening and Baseline visit
4)Subjects who have IGA score = 3 at the Screening and Baseline visits
5)Subjects who have at least 10% of total body surface area affected by AD at the Screening visit and Baseline visit
6)Subjects who can give written informed consent
7)Subjects must have applied a stable dose of a bland emollient to affected areas for at least 7 days before the Baseline visit and be willing to continue for the duration of the study
8)Male subjects must abstain from heterosexual activities or agree to use a condom through 30 days after the final dose of study drug. Women of childbearing potential (WOCBP) must abstain from heterosexual activities or agree to use effective contraception through 30 days after the final dose of study drug.
Effective contraception for males and/or WOCBP includes:
-Blockage methods – spermicides and condoms/spermicides and vaginal diaphragm for contraception, vaginal sponges or cervical cap (where available)
-Oral contraceptives (the pill”) for at least 1 month
-Depot or injectable birth control or implantable contraception (e.g., Implanon)
-Intrauterine device
-Documented evidence of surgical sterilization at least 6 months prior to Screening visit i.e., tubal ligation or hysterectomy for women or vasectomy for men
-Women who are post-menopausal, as documented by measurement of follicle stimulating hormone
1.Systemic infection or local infection requiring prohibited medications at screening
2.Subjects who underwent the following treatments within 4 weeks prior to Baseline visit or are scheduled to receive the following treatments within 4 weeks from Baseline at the discretion of investigator:
a.Use of immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate)
b.Phototherapy for AD
c.Any other systemic therapy used to treat AD or symptoms of AD (approved or off-label use)
3.Use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within at least 2 weeks prior to baseline
4.History of anaphylaxis to any biologic therapy or vaccine
5.History of Guillain-Barré syndrome
6.Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
7.Any allergen immunotherapy within 4 months prior to or throughout the study
8.A value outside the specified range of 90 mmHg – 140 mmHg for systolic blood pressure and 50 mmHg –90 mmHg for diastolic blood pressure (both inclusive) at Screening (can be repeated once at screening as per Principal Investigator’s [PI’s] discretion).
9.Receipt of live vaccines within 12 weeks prior to Baseline visit
10.Receipt of the following biologics:
a.Cell depleting agents such as rituximab: within 6 months prior to Baseline or within time to return of lymphocyte count to normal, whichever is longer
b.Other biologics: within 5 half-lives or within 16 weeks prior to Baseline, whichever is longer
11.Active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus (HCV)
12.Female subjects who are pregnant or lactating or female subjects of childbearing potential who have a pregnancy plan or do not agree to use acceptable methods of contraception, excluding females who are in post-menopausal or surgically infertile (bilateral tubal ligation, bilateral oophorectomy or complete hysterectomy)
13.Receipt of any investigational drugs within 8 weeks prior to Baseline, within 5 half lives of investigational drug or participated in any clinical trials of medical device
14.Diagnosed with either primary or recurrent malignancy within 5 years from Screening
15.Liver malfunctions with aspartate aminotransferase (AST) / alanine aminotransferase (ALT) level >2 x upper limit of normal (ULN) at Screening
16.Renal malfunctions with creatinine level >2 x ULN at Screening
17.QTc prolongation >470 msec or other significant electrocardiogram (ECG) abnormality noted within 14 days of treatment
18.History of hypersensitivity to antibiotics and antimicrobial agents
19.History of significant AEs during stem cell therapies
20.Allergic or hypersensitivity reaction to the IP, drug of similar class or ingredients [bovine serum, dimethyl sulfoxide (DMSO)]
21.Failure to comply with emollient application instructions prior to baseline, per diary
22.Subjects who, in the opinion of the investigator, have other unstable intercurrent diseases that confound safety and efficacy assessment
23.Planned or anticipated major surgical procedure during the subject's participation in this study
24.Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physical Exam, Reported AEs and concomitant medications, Vital signs (blood pressure, heart rate, body temperature, respiratory rate) measurements, ECG measurements and findings, Hematology, chemistry and urinalysis laboratory parameters, Infection, Embolism, D-dimer;the percentage of subjects who have EASI-50
- Secondary Outcome Measures
Name Time Method Score change from Baseline in EASI score;Percentage of subjects who have EASI-75 and EASI-90 (improvement of =75% and =90%, respectively, in EASI score from baseline);Percentage of subjects who have the IGA score of 0 or 1;Percentage of subjects whose IGA score is decreased by 2 points or more;Score change from Baseline on pruritus NRS;Percentage of subjects whose pruritus NRS is improved by 3 points or more;Percentage change from Baseline in BSA affected by AD;Score change from Baseline in the SCORAD index;Score change from Baseline in the DLQI;Score change from Baseline the POEM;Change from Baseline in biomarkers (IgE, eosinophil count, IL-13, IL-17, thymus and activation-regulated chemokine [TARC] and IL-22)