Long-Term Safety Follow-Up Study of SCM-AGH in Subjects Who Participated and Administered SCM-AGH in to Severe Atopic Dermatitis Clinical Trials

• Conditions: Dermatitis, Atopic

• Registration Number: NCT04185584
• Lead Sponsor: SCM Lifescience Co., LTD.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-04
• Study Start: 2020-08-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Subjects who provide written informed consent
2. Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study
3. Subjects who are willing to comply with the visit schedule and study requirements for reporting relevant information to the site.

Exclusion Criteria

1. Subjects who are unable to comply with the visit schedule prior to Week 240 after first dose of SCM AGH

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term concomitant medication assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD)	Up to 5 Years	Number of occurrence of use of medications related to adverse events
Long-term safety assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD)	Up to 5 Years	Number of occurrence of treatment-related adverse events (≥ Grade 3 in severity (NCI-CTCAE, v5.0))

Secondary Outcome Measures

Name	Time	Method
Outcome of unresolved Adverse Events(AEs) from ADT2002 study	Up to 5 Years
Number of occurrence of Abnormal, clinically significant in hematology laboratory results	Up to 5 Years	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
Number of occurrence of Abnormal, clinically significant in chemistry laboratory results	Up to 5 Years	Chemistry panel: hemoglobin, hematocrit, red blood cells, white blood cells (WBC), WBC differential count, platelets
Number of occurrence of Abnormal, clinically significant in urinalysis laboratory results	Up to 5 Years	Urinalysis panel: specific gravity (SG), color, pH, protein, glucose, bilirubin, blood, WBC
Clinically important physical examination findings	Up to 5 Years	Number of abnormality in general appearance, skin, eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph nodes, musculoskeletal and neurologic.

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of