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

NCT ID: NCT04185584

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-25

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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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

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Dermatitis, Atopic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Not Applicable (Observational Study)

Not Applicable (Observational Study)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SCM Lifescience Co., LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gwang Seong Choi, MD-Ph.D

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

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Inha University Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ADT2002-LTFU

Identifier Type: -

Identifier Source: org_study_id

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