REZOLVE-AD: A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
|
| Experimental: Arm A1 Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
|
| Experimental: Arm A2 Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
|
| Experimental: Arm B Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
|
| Experimental: Arm B1 Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
|
| Experimental: Arm B2 Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
|
| Experimental: Arm C Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
|
| Experimental: Arm C1 Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
|
| Experimental: Arm C2 Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
|
| Placebo Comparator: Arm D Placebo every 2 weeks during the induction period |
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
|
| Placebo Comparator: Arm D1 Placebo every 4 weeks during the maintenance period |
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
|
| Experimental: Escape Therapy (open-label) Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period |
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16 [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 [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) [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) [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) [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 [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 [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 [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) [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) [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 [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 [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 [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 [From Week 0 through Week 54]
- Rezpegaldesleukin plasma concentration assessed throughout the study [Through end of study (week 54)]
- Incidence of Serious Adverse Events (SAEs) [Through end of study (week 54)]
- Incidence of Treatment Emergent Adverse Events (TEAEs) [Through end of study (week 54)]
Eligibility Criteria
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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | California Allergy and Asthma Medical Group - Los Angeles - CRN - PPDS | Los Angeles | California | United States | 93551-1411 |
| 2 | Clinical Science Institute | Santa Monica | California | United States | 90404-2182 |
| 3 | Marietta Dermatology & The Skin Cancer Center - Marietta | Marietta | Georgia | United States | 30060-1047 |
| 4 | DermDox Centers for Dermatology | Camp Hill | Pennsylvania | United States | 17011 |
| 5 | Dermatology Specialists of Spokane | Spokane | Washington | United States | 99202-1332 |
Sponsors and Collaborators
- Nektar Therapeutics
Investigators
- Study Director: Study Director, Nektar Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-358-05