NCT04185584

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 92 (estimated)
• Sponsor: SCM Lifescience Co., LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
OTHER	Not Applicable (Observational Study)	Not Applicable (Observational Study)

Timeline

• Start date: 2020-08-25
• Primary completion: 2025-01-31
• Completion: 2025-03-31
• First posted: 2019-12-04
• Last updated: 2021-03-17

Locations

1 site across 1 country: South Korea