Atopic DermatitisPhase 3NCT06216392
Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis
A Phase 3 study testing GR1802 injection in people with Atopic Dermatitis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- GR1802 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Jan 2024to Jan 2026
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with AD according to Williams criteria with a history of at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥4 at Baseline.
- Inadequate response or intolerance to topical glucocorticoid therapy for AD within 6 months prior to screening.
Who cannot join
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial.
- Women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study.
- Other
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital
Shanghai, Shanghai Municipality, 200000
Jinhua Xu, PhD., +86-021-52889999, luhanyu@genrixbio.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Trial Evaluating the Efficacy, Safety, and Immunogenicity of GR1802 Injection in Patients With Moderate to Severe Atopic Dermatitis
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- GR1802 injection, placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR1802 injectionBiological
150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
placeboBiological
0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Experimental: GR1802 | Experimental | GR1802 injection 300mg every two weeks for 52-week treatment. Receives: Biological: GR1802 injection |
| Placebo | Placebo comparator | Placebo every two weeks for 16-week treatment. Crossover to GR1802 injection for another 36 weeks Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving EASI-75 at week 16
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Measured: at Week 16
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16
IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: at Week 16
Secondary outcomes (8)
Percent change of EASI score from baseline
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Measured: Baseline up to Week 52
Percent change of NRS score from baseline
The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)
Measured: Baseline up to Week 52
Body surface area (BSA) of involvement of atopic dermatitis
Change from baseline in percent of BSA
Measured: Baseline up to Week 52
Changes from baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life. It is a 10-question questionnaire with a score of 0 (not at all) to 3 (very much) for each question. A high score is indicative of a poor quality of life.
Measured: Baseline up to Week 52
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Measured: Baseline up to Week 60
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
anti-drug antibody (ADA) and neutralizing antibody (Nab)
Measured: Baseline up to Week 60
Changes from baseline in Scoring Atopic Dermatitis Index (SCORAD)
SCORAD ("SCORing Atopic Dermatitis") is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis as objectively as possible.
Measured: Baseline up to Week 52
Changes from baseline in The Patient-Oriented Eczema Measures for Eczema(POEM)
The Patient Oriented Eczema Measure (POEM) is a tool used for monitoring atopic eczema severity. It focuses on the illness as experienced by the patient.
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJan 2026 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216392
- Sponsor's protocol ID
- GR1802-004
- Status last verified
- Dec 2023
- First submitted
- 11 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Trial Evaluating the Efficacy, Safety, and Immunogenicity of GR1802 Injection in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06216392
- Acronym / sponsor ID
- GR1802-004
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 22 Jan 2024 (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 multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: GR1802 | Experimental | Biological: GR1802 injectionGR1802 injection 300mg every two weeks for 52-week treatment. |
| Placebo | Placebo comparator | Biological: placeboPlacebo every two weeks for 16-week treatment. Crossover to GR1802 injection for another 36 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with AD according to Williams criteria with a history of at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥4 at Baseline.
- Inadequate response or intolerance to topical glucocorticoid therapy for AD within 6 months prior to screening.
Key exclusion criteria (5 listed)
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial.
- Women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study.
- Other
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 |
|---|---|---|
| GR1802 injection150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous | Biological | Experimental: GR1802 |
| placebo0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous | Biological | Placebo |
Primary outcome
Proportion of subjects achieving EASI-75 at week 16
Time frame: at Week 16
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16
Time frame: at Week 16
IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
8 secondary outcomes
Percent change of EASI score from baseline
Time frame: Baseline up to Week 52
Percent change of NRS score from baseline
Time frame: Baseline up to Week 52
Body surface area (BSA) of involvement of atopic dermatitis
Time frame: Baseline up to Week 52
Changes from baseline in Dermatology Life Quality Index (DLQI)
Time frame: Baseline up to Week 52
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: Baseline up to Week 60
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: Baseline up to Week 60
Changes from baseline in Scoring Atopic Dermatitis Index (SCORAD)
Time frame: Baseline up to Week 52
Changes from baseline in The Patient-Oriented Eczema Measures for Eczema(POEM)
Time frame: Baseline up to Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GR1802 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?
The sponsor lists 2 inclusion and 5 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 22 Jan 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jinhua Xu, PhD. (021-52889999, xjhhsyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving EASI-75 at week 16 (time frame: at Week 16). 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 22 Jan 2024.