Atopic Dermatitis Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 450 |
Est. completion date | January 2026 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. Inadequate response or intolerance to topical glucocorticoid therapy for AD within 6 months prior to screening. Exclusion Criteria: 1. Not enough washing-out period for previous therapy. 2. Concurrent disease/status which may potentially affect the efficacy/safety judgement. 3. Abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial. 4. Women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study. 5. Other |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Genrix (Shanghai) Biopharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | at Week 16 | |
Primary | 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). | at Week 16 | |
Secondary | 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). | Baseline up to Week 52 | |
Secondary | Percent change of NRS score from baseline | The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch) | Baseline up to Week 52 | |
Secondary | Body surface area (BSA) of involvement of atopic dermatitis | Change from baseline in percent of BSA | Baseline up to Week 52 | |
Secondary | 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. | Baseline up to Week 52 | |
Secondary | 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. | Baseline up to Week 60 | |
Secondary | Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab) | anti-drug antibody (ADA) and neutralizing antibody (Nab) | Baseline up to Week 60 | |
Secondary | 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. | Baseline up to Week 52 | |
Secondary | 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. | Baseline up to Week 52 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05018806 -
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
|
Phase 2 | |
Terminated |
NCT03847389 -
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
|
Phase 1/Phase 2 | |
Completed |
NCT04090229 -
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
|
Phase 1 | |
Active, not recruiting |
NCT05388760 -
Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
|
Phase 2 | |
Completed |
NCT05530707 -
Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer
|
N/A | |
Completed |
NCT02595073 -
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
|
Phase 3 | |
Recruiting |
NCT05509023 -
Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)
|
Phase 2 | |
Recruiting |
NCT05048056 -
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT04598269 -
Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
|
Phase 2 | |
Recruiting |
NCT03936335 -
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
|
||
Withdrawn |
NCT03089476 -
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
|
N/A | |
Recruiting |
NCT05029895 -
A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
|
||
Terminated |
NCT03654755 -
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT04556461 -
Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function
|
Phase 2 | |
Recruiting |
NCT04818138 -
BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort
|
N/A | |
Completed |
NCT03719742 -
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer
|
N/A | |
Completed |
NCT05375955 -
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
|
Phase 2 | |
Completed |
NCT03441568 -
In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
|
N/A | |
Recruiting |
NCT06366932 -
Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models
|
Phase 4 | |
Completed |
NCT03304470 -
A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis
|
Phase 2 |