A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
Purpose
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 participants with moderate to severe atopic dermatitis. The estimated duration is 15-35 days for screening and then up to approximately day 378 (last dose on day 280 + 98 days safety follow-up) for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.
Condition
- Moderate to Severe Atopic Dermatitis
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults (18 to 70 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 Criteria
- 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 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 resected with no evidence of metastatic disease for 3 years or cervical carcinoma in situ, with no evidence of recurrence within the 5 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 or hepatitis C 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Patients will be randomized initially to 1 of 4 groups (A dose regimen, B dose regimen, C dose regimen, or D dose regimen [placebo]) for the blinded induction period. At Week 16, the start of the blinded maintenance period, patients who responded well to treatment will be re-randomized within their previously assigned groups to either maintenance regimen 1 or maintenance regimen 2. At Week 16, patients without an adequate response during the blinded induction period may be assigned to receive open label escape therapy through the maintenance period of the study (up to Week 40); however, patients receiving escape therapy with inadequate improvement in disease severity will be discontinued from the study therapy at week 32. Any patients enrolled into the blinded maintenance period with acute exacerbation of atopic dermatitis may be eligible to receive open label escape therapy instead.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A |
Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period |
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|
Experimental Arm A1 |
Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period |
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|
Experimental Arm A2 |
Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period |
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|
Experimental Arm B |
Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period |
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|
Experimental Arm B1 |
Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period |
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Experimental Arm B2 |
Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period |
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Experimental Arm C |
Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period |
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Experimental Arm C1 |
Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period |
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Experimental Arm C2 |
Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period |
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Placebo Comparator Arm D |
Placebo every 2 weeks during the induction period |
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Placebo Comparator Arm D1 |
Placebo every 4 weeks during the maintenance period |
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Experimental Escape Therapy (open-label) |
Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period |
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Recruiting Locations
University of Texas Health Science Center at Houston
Bellaire, Texas 77401-3535
Bellaire, Texas 77401-3535
More Details
- Status
- Recruiting
- Sponsor
- Nektar Therapeutics