A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

Korábbi kezelés

• Prior use of systemic immune modulating therapies for AD (i.e., JAK inhibitors or biologics)
• Treatment with a live (attenuated) immunization within 12 weeks prior to screening.
• Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
• Concurrent participation in any other investigational clinical study.

Más betegség

• Other skin conditions that would interfere with assessment of AD
• Any malignancies or history of malignancies within 5 years prior to randomization (except for basal cell or squamous epithelial carcinomas of the skin that have been successfully treated with no evidence of metastatic disease for 3 years or cervical carcinoma in situ that has been successfully treated, with no evidence of recurrence within the 3 years prior to randomization).
• Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
• Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening.

Egyéb

• Men and women (of reproductive potential) unwilling to use highly effective birth control and women who are pregnant or breastfeeding.

• Adults (from at least 18 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer prior to screening.
• AD disease severity at screening and randomization:
  • EASI of 16 or higher
  • IGA of 3 or 4
  • BSA of 10% or more
• Documented history, within 6 months prior to the screening visit, of either inadequate response or inadvisability of topical treatments.
• Able to complete patient questionnaires.
• Able and willing to comply with requested study visits and procedures.
• Able and willing to provide written informed consent.