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This is a long-term safety follow-up study of the Phase I/II multicenter study of SCM-AGH in subjects with moderate to severe atopic dermatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol ADT2002 (ClinicalTrials.gov ID: NCT04179760) will be eligible for this long-term follow-up protocol.
Subjects who meet all eligibility criteria for Long Term Follow Up(LTFU) study participation at the ADT2002 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not Applicable (Observational Study) | Other | Not Applicable (Observational Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD) | Number of occurrence of treatment-related adverse events (≥ Grade 3 in severity (NCI-CTCAE, v5.0)) | Up to 5 Years |
| Long-term concomitant medication assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD) | Number of occurrence of use of medications related to adverse events | Up to 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome of unresolved Adverse Events(AEs) from ADT2002 study | Up to 5 Years | |
| Clinically important physical examination findings | Number of abnormality in general appearance, skin, eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph nodes, musculoskeletal and neurologic. |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects who are unable to comply with the visit schedule prior to Week 240 after first dose of SCM AGH
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Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study (ClinicalTrials.gov ID: NCT04179760)
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| Name | Affiliation | Role |
|---|---|---|
| Gwang Seong Choi, MD-Ph.D | Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Incheon | South Korea |
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| Up to 5 Years |
| Number of occurrence of Abnormal, clinically significant in hematology laboratory results | Hematology panel: alkaline phosphatase [ALP], blood urea nitrogen, creatinine, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), albumin, total protein, total bilirubin, uric acid, glucose, cholesterol, sodium, potassium, chloride, calcium, phosphorus | Up to 5 Years |
| Number of occurrence of Abnormal, clinically significant in chemistry laboratory results | Chemistry panel: hemoglobin, hematocrit, red blood cells, white blood cells (WBC), WBC differential count, platelets | Up to 5 Years |
| Number of occurrence of Abnormal, clinically significant in urinalysis laboratory results | Urinalysis panel: specific gravity (SG), color, pH, protein, glucose, bilirubin, blood, WBC | Up to 5 Years |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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