Dermatitis, AtopicNCT04185584
Long-Term Safety Follow-Up Study of SCM-AGH in Subjects Who Participated and Administered SCM-AGH in to Severe Atopic Dermatitis Clinical Trials
An observational study of Dermatitis, Atopic, run by SCM Lifescience Co., LTD. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Not Applicable (Observational Study)
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Aug 2020to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study (ClinicalTrials.gov ID: NCT04179760)
Who may be able to join
- Subjects who provide written informed consent
- Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study
- Subjects who are willing to comply with the visit schedule and study requirements for reporting relevant information to the site.
Who cannot join
- 1. Subjects who are unable to comply with the visit schedule prior to Week 240 after first dose of SCM AGH
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Long-Term Safety Follow-Up Study of SCM AGH in Subjects Who Participated in the ADT2002 Study
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.
Read the 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
- Being tested
- Not Applicable (Observational Study)
- Keywords
- SCM-AGH, Atopic Dermatitis, Stem cell therapy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not Applicable (Observational Study)Other
Not Applicable (Observational Study)
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 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
Measured: Up to 5 Years
Secondary outcomes (5)
Outcome of unresolved Adverse Events(AEs) from ADT2002 study
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start25 Aug 2020
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCM Lifescience Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gwang Seong Choi, MD-Ph.D, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185584
- Sponsor's protocol ID
- ADT2002-LTFU
- Status last verified
- Mar 2021
- First submitted
- 28 Nov 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Safety Follow-Up Study of SCM AGH in Subjects Who Participated in the ADT2002 Study
- ClinicalTrials.gov ID
- NCT04185584
- Acronym / sponsor ID
- ADT2002-LTFU
- Conditions
- Dermatitis, Atopic
- Keywords
- SCM-AGH, Atopic Dermatitis, Stem cell therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- SCM Lifescience Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study (ClinicalTrials.gov ID: NCT04179760)
Key inclusion criteria (3 listed)
- Subjects who provide written informed consent
- Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study
- Subjects who are willing to comply with the visit schedule and study requirements for reporting relevant information to the site.
Key exclusion criteria (1 listed)
- 1. Subjects who are unable to comply with the visit schedule prior to Week 240 after first dose of SCM AGH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not Applicable (Observational Study)Not Applicable (Observational Study) | Other | – |
Primary outcome
Long-term safety assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD)
Time frame: Up to 5 Years
Number of occurrence of treatment-related adverse events (≥ Grade 3 in severity (NCI-CTCAE, v5.0))
Long-term concomitant medication assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD)
Time frame: Up to 5 Years
Number of occurrence of use of medications related to adverse events
5 secondary outcomes
Outcome of unresolved Adverse Events(AEs) from ADT2002 study
Time frame: Up to 5 Years
Clinically important physical examination findings
Time frame: Up to 5 Years
Number of occurrence of Abnormal, clinically significant in hematology laboratory results
Time frame: Up to 5 Years
Number of occurrence of Abnormal, clinically significant in chemistry laboratory results
Time frame: Up to 5 Years
Number of occurrence of Abnormal, clinically significant in urinalysis laboratory results
Time frame: Up to 5 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Related trials for Dermatitis, Atopic
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwang Seong Choi, MD-Ph.D principal investigator
Inha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by SCM Lifescience Co., LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD) (time frame: Up to 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.