Moderate-to-Severe AD
Conditions
Interventions
Group of Moderate-to-Severe AD:QX005N 600mg Q4W
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participation in a prior clinical trial of QX005N for AD (parent study: QX005NA-02 (PART B)) and met one of the following: a.Received study treatment and adequately completed the last visit assessments of the parent study as defined. b.Treatment discontinuation due to a poor compliance event or a AE that was deemed not related to QX005N, and complete the early withdrawal visit, according to the judgement of the investigator and the sponsor, the factor that led to the patient's early termination of treatment has disappeared/no longer affect the subject's participation in this study. 2. No birth plan and willing to use adequate birth control from the start of this study to 6 months after the last dose. 3. With ability to understand contents of informed consent form (ICF), and willing to sign and comply with terms in ICF. 4. Willing and able to comply with the planned clinic visits.
Exclusion criteria
Exclusion criteria: 1. Participation in a prior clinical trial of QX005N for AD (parent study: QX005NA-02 (PART B)) and met one of the following: a.Patients developed a SAE that was deemed related to QX005N, and in the opinion of the investigator, the factors that led to the patient's early termination of treatment may present an unreasonable risk for the patient. b.Patients developed a AE that was deemed related to QX005N, and in the opinion of the investigator, the factors that led to the patient's early termination of treatment may present an unreasonable risk for the patient. c.Patients developed other conditions that lead to early termination of treatment, and in the opinion of the investigator, the factors that led to the patient's early termination of treatment may present an unreasonable risk for the patient. 2. Allergic to ingredients or excipients of the study drugs. 3. Pregnant or breast-feeding women, or women who plan to pregnant or breast-feeding during the whole study. 4.Treatment with drugs that target IL-4Ra, IL-4 or IL-13(exclude QX005N) before the screening visit. 5.With history of or presence of diseases at the screening visit as below: a.Systematic chronic or acute infection requiring with treatment with antibodies, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the screening visit, or herpes simplex infection within 2 weeks before the screening visit, or superficial skin infection within 1 weeks before the screening visit. (If have an infection, the patient can be re-screened after infection has subsided for only once). b.History of or suspected immunosuppressive disorders, including invasive occasional infectious diseases (eg. histoplasmosis, listeriosis, coccidiodomycosis, pneumocystosis, and aspergillosis), even if the infection has subsided, or there are unusually frequent, recurrent or long-term infections,the patient should be ruled out. c. Any other active inflammatory skin diseases that,in the opinion od the investigator, might interfere with the evaluation in this study at the screening visit. d. Any other medical or psychological history that, in the opinion od the investigator, may present an unreasonable risk to the study patientas a result of his/her participation in this clinical trial may make patient’s participation unreliable, or may interfere with study assessments, such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, hematological system diseases, immune system diseases, mental diseases, etc. 6. Infectious disease meet the following criteria at the screening visit: a.History of tuberculosis, or active or latent TB infection at the time of screening (according to T-spot.TB or QuantiFERON-TB Gold test results). b.Positive hepatitis B surface antigen (or negative HBsAg plus positive HBcAb plus positive HBV-DNA). c.Positive hepatitis C antibody plus positive HCV-RNA. d.Positive treponema pallidum antibody plus positive RPR test. e.History of HIV infection, or positive HIV antibody. 7. Prior/concomitant therapy: a.Treatment with medium-to-superpotent TCS, or TCI uses on areas other than face, neck, genitalwithin 1 weeks before the baseline visit. b.Treatment with mPDE-4 inhibitor, such as Crisaborole, Roflumilast, Apremilast, etc., or JAK inhibitor, such as Ruxolitinib, Baricitinib, Tofacitinib, Upadacitinib, Abrocitinib,etc. c.Treatment with systematic traditional Chinese medicine therapies within 2 weeks before the baseline visit, or w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidenceof AEs (AEs means TEAEs in this study) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of SAEs;Proportion of subjects with EASI-75;Proportion of subjects with IGA of 0 (clear) or 1 (almost clear) and a reduction of at least 2-point;Proportion of subjects with a reduction of at least 4-point of PP-NRS score;Change and percent change in EASI score;Change and percent change in PP-NRS score;Change and percent change in BSA affected by AD;Change and percent change in DLQI score; | — |
Countries
China
Contacts
Public ContactJin Hongzhong
Peking Union Medical College Hospital
Outcome results
None listed