A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (REZOLVE-AD)
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| ClinicalTrials.gov Identifier: NCT06136741 |
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Recruitment Status :
Recruiting
First Posted : November 18, 2023
Last Update Posted : May 10, 2024
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Sponsor:
Nektar Therapeutics
Information provided by (Responsible Party):
Nektar Therapeutics
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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 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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Moderate to Severe Atopic Dermatitis | Drug: Rezpegaldesleukin Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 396 participants |
| 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. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 54-Week Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis |
| Actual Study Start Date : | October 23, 2023 |
| Estimated Primary Completion Date : | May 30, 2025 |
| Estimated Study Completion Date : | December 31, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Eczema
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A
Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
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Experimental: Arm A1
Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
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Experimental: Arm A2
Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
Drug: Placebo Pharmaceutical form: Injection solution Route of administration: subcutaneous |
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Experimental: Arm B
Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
Drug: Placebo Pharmaceutical form: Injection solution Route of administration: subcutaneous |
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Experimental: Arm B1
Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
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Experimental: Arm B2
Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
Drug: Placebo Pharmaceutical form: Injection solution Route of administration: subcutaneous |
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Experimental: Arm C
Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
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Experimental: Arm C1
Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
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Experimental: Arm C2
Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
Drug: Placebo Pharmaceutical form: Injection solution Route of administration: subcutaneous |
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Placebo Comparator: Arm D
Placebo every 2 weeks during the induction period
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Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous |
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Placebo Comparator: Arm D1
Placebo every 4 weeks during the maintenance period
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Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous |
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Experimental: Escape Therapy (open-label)
Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period
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Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
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Primary Outcome Measures :
- Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16 [ Time Frame: Week 0 and Week 16 ]The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Secondary Outcome Measures :
- Proportion of patients at week 16 achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and at least a 2-point reduction from their baseline value [ Time Frame: Week 0 and Week 16 ]The vIGA-AD scale ranges from 0 to 4, with higher score indicating more severe atopic dermatitis.
- Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 75% relative to their baseline score (EASI-75) [ Time Frame: Week 0 and Week 16 ]The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
- Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 90% relative to their baseline score (EASI-90) [ Time Frame: Week 0 and Week 16 ]The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
- Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 50% relative to their baseline score (EASI-50) [ Time Frame: Week 0 and Week 16 ]The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
- Proportion of patients at week 16 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of patients with a 4-point or greater Itch NRS at baseline [ Time Frame: Week 0 and Week 16 ]The itch NRS goes from 0 to 10, with higher score indicating more severe itch.
- Proportion of patients at week 16 achieving a SCORing Atopic Dermatitis Index (SCORAD) reduction of 75% from their baseline value [ Time Frame: Week 0 and Week 16 ]The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
- Proportion of patients at week 16 achieving a SCORAD reduction of 50% from their baseline value [ Time Frame: Week 0 and Week 16 ]The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
- Mean change from baseline over the period between week 0 and week 54 in Eczema Area and Severity Index (EASI) [ Time Frame: From Week 0 through Week 54 ]The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
- Mean percent change from baseline over the period between week 0 and week 54 in Eczema Area and Severity Index (EASI) [ Time Frame: From Week 0 through Week 54 ]The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.
- Mean change from baseline over the period between week 0 and week 54 in SCORAD [ Time Frame: From Week 0 through Week 54 ]The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
- Mean percent change from baseline over the period between week 0 and week 54 in SCORAD [ Time Frame: From Week 0 through Week 54 ]The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.
- Mean change from baseline over the period between week 0 and week 54 in body surface area (BSA) involvement [ Time Frame: From Week 0 through Week 54 ]
- Mean percent change from baseline over the period between week 0 and week 54 in body surface area (BSA) involvement [ Time Frame: From Week 0 through Week 54 ]
- Rezpegaldesleukin plasma concentration assessed throughout the study [ Time Frame: Through end of study (week 54) ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Through end of study (week 54) ]
- Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Through end of study (week 54) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06136741
Contacts
| Contact: Nektar Recruitment | 855-482-8676 | StudyInquiry@nektar.com |
Locations
Show 47 study locations
Sponsors and Collaborators
Nektar Therapeutics
Investigators
| Study Director: | Study Director | Nektar Therapeutics |
| Responsible Party: | Nektar Therapeutics |
| ClinicalTrials.gov Identifier: | NCT06136741 |
| Other Study ID Numbers: |
23-358-05 |
| First Posted: | November 18, 2023 Key Record Dates |
| Last Update Posted: | May 10, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |