Atopic DermatitisPhase 1NCT06175143
A Study to Evaluate the Safety and Efficacy of GR2002 Injection in Patients With Atopic Dermatitis.
A Phase 1 study testing GR2002 injection in people with Atopic Dermatitis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase Ib clinical trial evaluating the safety tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR2002 Injection in patients with moderate to severe atopic dermatitis. The dosing period was 12 weeks and followed up to 20 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- GR2002 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2023to Oct 2024
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Patients need to meet Williams diagnostic criteria, have had AD for at least 1 year, and:EASI ≥16, IGA score ≥3, and AD involvement of ≥10% of BSA;
- Inadequate response or intolerance to prior topical glucocorticoid (TCS) therapy for the treatment of AD;
- Voluntary informed consent.
Main Exclusion Criteria:
- Current malignancy or history of malignancy;
- History of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
- Subjects may have active Mycobacterium tuberculosis infection;
- Systemic anti-infective therapy required for chronic or acute active infection within 4 weeks prior to the baseline visit;
- History of known or suspected immunosuppression;
- Presence of skin comorbidities that may interfere with evaluation;
- Suspected or confirmed allergy to the test drug (including excipients, similar drugs);
- History of alcohol or drug abuse within 3 months prior to screening；
- Pregnant or lactating women who need to breastfeed；
- Major surgery planned during the trial；
- The elution cycle of the drug of interest is not met at the baseline；
- Subjects of childbearing potential and partners refusing to use highly effective contraception.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jianzhong Zhang, PHD
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of GR2002 Injection in Patients With Moderate to Severe Atopic Dermatitis
This is a randomized, double-blind, placebo-controlled Phase Ib clinical trial evaluating the safety tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR2002 Injection in patients with moderate to severe atopic dermatitis. The dosing period was 12 weeks and followed up to 20 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- GR2002 injection
- Keywords
- TSLP
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR2002 injectionBiological
TSLP monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| GR2002 injection 1 | Experimental | GR2002 injection dose 1/Placebo，multiple-dose，Subcutaneous，high frequency Receives: Biological: GR2002 injection |
| GR2002 injection 2 | Experimental | GR2002 injection dose 2/Placebo，multiple-dose，Subcutaneous，high frequency Receives: Biological: GR2002 injection |
| GR2002 injection 3 | Experimental | GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，high frequency Receives: Biological: GR2002 injection |
| GR2002 injection 4 | Experimental | GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，low frequency Receives: Biological: GR2002 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence of AEs.
Measured: Within 20 weeks
Secondary outcomes (6)
Pharmacokinetics parameters
concentration of GR2002
Measured: Within 20 weeks
IGA Response
Proportion of subjects with an IGA score of 0-1 and a decrease of ≥2 points from baseline
Measured: Within 20 weeks
EASI 50/75/90 Response
Proportion of subjects with ≥50%, ≥75%, and ≥90% improvement in EASI score
Measured: Within 20 weeks
Percentage change in BSA score
Percentage change from baseline in BSA involvement in atopic dermatitis lesions
Measured: Within 20 weeks
Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3
Proportion of subjects with ≥4/3-point decrease in PP-NRS from baseline
Measured: Within 20 weeks
immunogenicity
Detection of anti-drug antibody(ADA)
Measured: Within 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Genrix (Shanghai) Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, PHD, Principal investigator, Peking University People's HospitalCheng Zhou, PHD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175143
- Sponsor's protocol ID
- GR2002-002
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of GR2002 Injection in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06175143
- Acronym / sponsor ID
- GR2002-002
- Conditions
- Atopic Dermatitis
- Keywords
- TSLP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 18 Dec 2023 (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 randomized, double-blind, placebo-controlled Phase Ib clinical trial evaluating the safety tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR2002 Injection in patients with moderate to severe atopic dermatitis. The dosing period was 12 weeks and followed up to 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GR2002 injection 1 | Experimental | Biological: GR2002 injectionGR2002 injection dose 1/Placebo，multiple-dose，Subcutaneous，high frequency |
| GR2002 injection 2 | Experimental | Biological: GR2002 injectionGR2002 injection dose 2/Placebo，multiple-dose，Subcutaneous，high frequency |
| GR2002 injection 3 | Experimental | Biological: GR2002 injectionGR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，high frequency |
| GR2002 injection 4 | Experimental | Biological: GR2002 injectionGR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，low frequency |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| GR2002 injectionTSLP monoclonal antibody | Biological | GR2002 injection 1, GR2002 injection 2, GR2002 injection 3, GR2002 injection 4 |
Primary outcome
Adverse events (AEs)
Time frame: Within 20 weeks
Incidence of AEs.
6 secondary outcomes
Pharmacokinetics parameters
Time frame: Within 20 weeks
IGA Response
Time frame: Within 20 weeks
EASI 50/75/90 Response
Time frame: Within 20 weeks
Percentage change in BSA score
Time frame: Within 20 weeks
Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3
Time frame: Within 20 weeks
immunogenicity
Time frame: Within 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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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.
Jianzhong Zhang, PHD principal investigator
Peking University People's Hospital
Cheng Zhou, PHD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GR2002 injection in people with Atopic Dermatitis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Dec 2023. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jianzhong Zhang, PHD (010-88325472, rmzjz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Within 20 weeks). 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 18 Dec 2023.