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New treatment option for Dermatitis, Atopic
Official title Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07042126
What this study is testing
What is 611?
611 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for dermatitis, atopic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- The people and their legal guardians are able to understand and comply with the research procedures, agree to participate in the research, and sign...
- When signing the informed consent form, the age should be ≥ 12 years old and \< 18 years old, gender is not restricted, and the body weight should be...
- During the screening process, patients were diagnosed with atopic dermatitis (AD) according to the Hanifin - Rajka criteria, and their AD medical...
- At the screening and baseline, the Eczema Area and Severity Index (EASI) score is ≥ 16 points.
- At the screening and baseline, the Investigator Global Assessment (IGA) score is ≥3 points.
You likely can't join if
- Merge other skin comorbidities that may interfere with the research evaluation.
- Combined with active parasitic infections (such as helminths) or suspected parasitic infections (people who have excluded active infections through...
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
- Randomly select patients with any malignant tumor diagnosed within the past 5 years or currently having the disease (excluding basal cell carcinoma...
- The subject had a severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks before randomization, or had an active...
- A history of known or suspected immunosuppression, including a history of invasive opportunistic infections (such as histoplasmosis, listeriosis...
See the full eligibility criteria
Who can join
- The people and their legal guardians are able to understand and comply with the research procedures, agree to participate in the research, and sign the Informed Consent Form (ICF).
- When signing the informed consent form, the age should be ≥ 12 years old and \< 18 years old, gender is not restricted, and the body weight should be ≥ 30 kg at the screening and baseline.
- During the screening process, patients were diagnosed with atopic dermatitis (AD) according to the Hanifin - Rajka criteria, and their AD medical history was evaluated by researchers to be ≥ 6 months (the diagnostic...
- At the screening and baseline, the Eczema Area and Severity Index (EASI) score is ≥ 16 points.
- At the screening and baseline, the Investigator Global Assessment (IGA) score is ≥3 points.
- At the time of screening and baseline, the affected body surface area (BSA) by atopic dermatitis (AD) is ≥10%.
- At baseline, the weekly average score of the Numerical Rating Scale (NRS) for pruritus was ≥ 4 points.
- people should have relevant medical records, other medical visit records, or other evidence within the previous year for researchers to evaluate. The people have poor how well it works of topical drug treatment, or are...
- Be willing to use a stable dose of emollient (moisturizer) on the affected areas of atopic dermatitis (AD) twice a day for at least 7 days before randomization and continue to use it throughout the study period.
- people with potential fertility (e.g., females who have experienced menarche or males who have had nocturnal emissions) must agree to avoid sexual activity or use highly effective contraceptive methods throughout the...
What rules you out
- Merge other skin comorbidities that may interfere with the research evaluation.
- Combined with active parasitic infections (such as helminths) or suspected parasitic infections (people who have excluded active infections through clinical and/or laboratory examinations before randomization can be...
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
- Randomly select patients with any malignant tumor diagnosed within the past 5 years or currently having the disease (excluding basal cell carcinoma that has been cured for ≥ 1 year, local cutaneous squamous cell...
- The subject had a severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks before randomization, or had an active infection requiring oral antibiotics within 2 weeks before randomization...
- A history of known or suspected immunosuppression, including a history of invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis); or those who...
- Those with evidence of active tuberculosis, or those who have had active tuberculosis in the past but cannot provide sufficient evidence of treatment, or those who are judged to potentially have active tuberculosis...
- The researchers believe that there are any diseases that are severe or unstable and may affect the safety of the people during the study and/or prevent the people from completing the study, including but not limited to...
- Currently receiving or having received the following treatments:
- Within the first 2 weeks randomly selected, patients have received topical drug treatment for atopic dermatitis (AD), such as TCS, TCI, PDE inhibitors, Janus kinase (JAK) inhibitors, etc.
- Within the first 4 weeks before randomization, the patients received systemic treatment with traditional Chinese medicine (TCM) of unknown nature or with therapeutic effects on AD. Or within the first 1 week before...
- Received systemic glucocorticoids or other immunosuppressants/immunomodulators (including but not limited to cyclosporine, mycophenolate mofetil, interferon γ [IFN-γ], JAK inhibitors, compound glycyrrhizin...
- Received phototherapy (including but not limited to narrow - band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen plus ultraviolet A [PUVA]), tanning beds, or any other light - emitting...
- Randomly selected patients who had received allergen-specific immunotherapy (SIT) within the previous 6 months.
- Received any monoclonal antibody therapy (such as dupilumab, etc.) within the first 4 months randomly or within 5 half-lives (whichever is longer) before randomization; Received any cell - depleting agents, including...
- As judged by the researchers, patients had no response or poor how well it works to previous treatment with anti-IL-4 and/or IL-13 drugs (such as dupilumab, etc.).
- Previously, 611 was used.
- Treatment of atopic dermatitis (AD) with prescription emollients or emollients containing additives is initiated during the screening period.
- Received live vaccines or live attenuated vaccines within the first 4 weeks before randomization.
- If any of the examination indicators before screening or randomization meet the following criteria and are judged by the researcher as unsuitable for inclusion in the study:TBIL≥1.5 ULN ;ALT/AST ≥2 ULN；Cr\>1.5 ULN...
- At the screening, the test results are positive for hepatitis B, positive for hepatitis C virus antibody (HCVAb), positive for human immunodeficiency virus antibody (HIVAb), and positive for serum Treponema pallidum...
- Used any investigational drugs within the first 8 weeks after randomization or 5 half-lives (whichever is longer);
- Had a history of alcohol or drug abuse within 6 months before randomization;
- Known to be allergic or intolerant to any components of the investigational drug;
- Planned or were expected to undergo major surgical operations during the study period;
- Pregnant women, women planning to become pregnant during the study period, or breastfeeding women;
- According to the investigator's judgment, the people were not suitable to participate in the study due to other diseases or reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Jinhua, Zhejiang, China
- Nanchang, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Jinhua, Zhejiang, China; Nanchang, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.