Status:
ACTIVE_NOT_RECRUITING
A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
Lead Sponsor:
Nektar Therapeutics
Conditions:
Moderate to Severe Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Prior use of systemic immune modulating therapies for AD (i.e., JAK inhibitors or biologics)
- Other skin conditions that would interfere with assessment of AD
- Treatment with a live (attenuated) immunization within 12 weeks prior to screening.
- Men and women (of reproductive potential) unwilling to use highly effective birth control and women who are pregnant or breastfeeding.
- 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.
- 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.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT06136741
Start Date
November 15 2023
End Date
December 31 2026
Last Update
December 23 2025
Active Locations (107)
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1
Nektar Investigative Site
Bryant, Arkansas, United States, 72022
2
Nektar Investigative Site
Fountain Valley, California, United States, 92708
3
Nektar Investigative Site
Los Angeles, California, United States, 90017
4
Nektar Investigative Site
Los Angeles, California, United States, 90025