Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06136741




Registration number
NCT06136741
Ethics application status
Date submitted
13/11/2023
Date registered
18/11/2023
Date last updated
16/07/2024

Titles & IDs
Public title
A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
23-358-05
Universal Trial Number (UTN)
Trial acronym
REZOLVE-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rezpegaldesleukin
Treatment: Drugs - Placebo

Experimental: Arm A - Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period

Experimental: Arm A1 - Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period

Experimental: Arm A2 - Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period

Experimental: Arm B - Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period

Experimental: Arm B1 - Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period

Experimental: Arm B2 - Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period

Experimental: Arm C - Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period

Experimental: Arm C1 - Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period

Experimental: Arm C2 - Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period

Placebo comparator: Arm D - Placebo every 2 weeks during the induction period

Placebo comparator: Arm D1 - Placebo every 4 weeks during the maintenance period

Experimental: Escape Therapy (open-label) - Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period


Treatment: Drugs: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous

Treatment: Drugs: Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16
Timepoint [1] 0 0
Week 0 and Week 16
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 0 and Week 16
Secondary outcome [2] 0 0
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 75% relative to their baseline score (EASI-75)
Timepoint [2] 0 0
Week 0 and Week 16
Secondary outcome [3] 0 0
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 90% relative to their baseline score (EASI-90)
Timepoint [3] 0 0
Week 0 and Week 16
Secondary outcome [4] 0 0
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 50% relative to their baseline score (EASI-50)
Timepoint [4] 0 0
Week 0 and Week 16
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Week 0 and Week 16
Secondary outcome [6] 0 0
Proportion of patients at week 16 achieving a SCORing Atopic Dermatitis Index (SCORAD) reduction of 75% from their baseline value
Timepoint [6] 0 0
Week 0 and Week 16
Secondary outcome [7] 0 0
Proportion of patients at week 16 achieving a SCORAD reduction of 50% from their baseline value
Timepoint [7] 0 0
Week 0 and Week 16
Secondary outcome [8] 0 0
Mean change from baseline over the period between week 0 and week 54 in Eczema Area and Severity Index (EASI)
Timepoint [8] 0 0
From Week 0 through Week 54
Secondary outcome [9] 0 0
Mean percent change from baseline over the period between week 0 and week 54 in Eczema Area and Severity Index (EASI)
Timepoint [9] 0 0
From Week 0 through Week 54
Secondary outcome [10] 0 0
Mean change from baseline over the period between week 0 and week 54 in SCORAD
Timepoint [10] 0 0
From Week 0 through Week 54
Secondary outcome [11] 0 0
Mean percent change from baseline over the period between week 0 and week 54 in SCORAD
Timepoint [11] 0 0
From Week 0 through Week 54
Secondary outcome [12] 0 0
Mean change from baseline over the period between week 0 and week 54 in body surface area (BSA) involvement
Timepoint [12] 0 0
From Week 0 through Week 54
Secondary outcome [13] 0 0
Mean percent change from baseline over the period between week 0 and week 54 in body surface area (BSA) involvement
Timepoint [13] 0 0
From Week 0 through Week 54
Secondary outcome [14] 0 0
Rezpegaldesleukin plasma concentration assessed throughout the study
Timepoint [14] 0 0
Through end of study (week 54)
Secondary outcome [15] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [15] 0 0
Through end of study (week 54)
Secondary outcome [16] 0 0
Incidence of Treatment Emergent Adverse Events (TEAEs)
Timepoint [16] 0 0
Through end of study (week 54)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
396
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [2] 0 0
Premier Specialists - Kogarah
Recruitment hospital [3] 0 0
Westmead Hospital-Cnr Hawkesbury and Darcy Rds - Westmead
Recruitment hospital [4] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [5] 0 0
North Eastern Health Specialists - Probity - PPDS - Campbelltown
Recruitment hospital [6] 0 0
Sinclair Dermatology-East Melbourne - East Melbourne
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Captain Stirling Medical Centre - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5074 - Campbelltown
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Gabrovo
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia-Grad
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Pleven
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sofia
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Québec
Country [25] 0 0
Croatia
State/province [25] 0 0
Grad Zagreb
Country [26] 0 0
Croatia
State/province [26] 0 0
Ivanic-Grad
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 10
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 5
Country [29] 0 0
Germany
State/province [29] 0 0
Baden-Württemberg
Country [30] 0 0
Germany
State/province [30] 0 0
Bayern
Country [31] 0 0
Germany
State/province [31] 0 0
Brandenburg
Country [32] 0 0
Germany
State/province [32] 0 0
Niedersachsen
Country [33] 0 0
Germany
State/province [33] 0 0
Nordrhein-Westfalen
Country [34] 0 0
Germany
State/province [34] 0 0
Sachsen
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Darmstadt
Country [37] 0 0
Germany
State/province [37] 0 0
Frankfurt
Country [38] 0 0
Germany
State/province [38] 0 0
Hamburg
Country [39] 0 0
Germany
State/province [39] 0 0
Lübeck
Country [40] 0 0
Germany
State/province [40] 0 0
Muenchen
Country [41] 0 0
Hungary
State/province [41] 0 0
Békés
Country [42] 0 0
Hungary
State/province [42] 0 0
Zala
Country [43] 0 0
Poland
State/province [43] 0 0
Dolnoslaskie
Country [44] 0 0
Poland
State/province [44] 0 0
Lódzkie
Country [45] 0 0
Poland
State/province [45] 0 0
Mazowieckie
Country [46] 0 0
Poland
State/province [46] 0 0
Podkarpackie
Country [47] 0 0
Poland
State/province [47] 0 0
Pomorskie
Country [48] 0 0
Poland
State/province [48] 0 0
Wielkopolskie
Country [49] 0 0
Poland
State/province [49] 0 0
Czestochowa
Country [50] 0 0
Poland
State/province [50] 0 0
Katowice
Country [51] 0 0
Poland
State/province [51] 0 0
Kraków
Country [52] 0 0
Poland
State/province [52] 0 0
Tarnów
Country [53] 0 0
Poland
State/province [53] 0 0
Wroclaw
Country [54] 0 0
Spain
State/province [54] 0 0
Alicante
Country [55] 0 0
Spain
State/province [55] 0 0
Córdoba
Country [56] 0 0
Spain
State/province [56] 0 0
Granada
Country [57] 0 0
Spain
State/province [57] 0 0
Sevilla
Country [58] 0 0
Spain
State/province [58] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nektar Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06136741
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Nektar Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nektar Recruitment
Address 0 0
Country 0 0
Phone 0 0
855-482-8676
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06136741