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

Dermatitis, Atopic Clinical Trial

Official title:

A Long-Term Safety Follow-Up Study of SCM AGH in Subjects Who Participated in the ADT2002 Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04185584
• Other study ID #: ADT2002-LTFU
• Status: Enrolling by invitation
• Start date: August 25, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2021
• Source: SCM Lifescience Co., LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 92
• Est. completion date: March 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Other:
• Not Applicable (Observational Study)
Not Applicable (Observational Study)

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
SCM Lifescience Co., LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Outcome of unresolved Adverse Events(AEs) from ADT2002 study		Up to 5 Years
Secondary	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.	Up to 5 Years
Secondary	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
Secondary	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
Secondary	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