A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

Moderate to Severe Atopic Dermatitis Clinical Trial

— REZOLVE-AD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136741
• Other study ID #: 23-358-05
• Status: Recruiting
• Phase: Phase 2
• Start date: October 23, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Nektar Therapeutics
• Contact: Nektar Recruitment
• Phone: 855-482-8676
• Email: StudyInquiry[@]nektar.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: December 31, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate to Severe Atopic Dermatitis

Intervention

Drug:
• Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
• Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Australia	North Eastern Health Specialists - Probity - PPDS	Campbelltown	South Australia
Australia	Holdsworth House Medical Practice	Darlinghurst	New South Wales
Australia	Sinclair Dermatology-East Melbourne	East Melbourne	Victoria
Australia	Premier Specialists	Kogarah	New South Wales
Australia	Captain Stirling Medical Centre	Nedlands	Western Australia
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland
Bulgaria	Medical Center Medconsult Pleven OOD	Pleven
Bulgaria	Medical Center Unimed EOOD	Sevlievo	Gabrovo
Bulgaria	AES - DRS - Medical Center Synexus Sofia EOOD	Sofia	Sofia-Grad
Bulgaria	Ambulatory for Specialized Medical Care- Group Practice in Dermatology - Clinic EuroDerma OOD	Sofia
Bulgaria	Diagnostic and Consulting Center Aleksandrovska EOOD	Sofia	Sofia-Grad
Bulgaria	Diagnostic Consultative Center XXVIII - Sofia - EOOD	Sofia	Sofia-Grad
Bulgaria	Medical Center Excelsior OOD - PPDS	Sofia	Sofia-Grad
Bulgaria	Medical Center Hera EOOD	Sofia
Canada	SimcoDerm Medical and Surgical Dermatology Centre	Barrie	Ontario
Canada	Dermatology Research Institute, Inc. - Probity - PPDS	Calgary	Alberta
Canada	Lynde Institute for Dermatology	Markham	Ontario
Canada	The Centre for Clinical Trials Inc.	Oakville	Ontario
Canada	Dermatology Ottawa Research Centre	Ottawa	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Saint-Louis	Québec
Canada	Centre For Dermatology and Cosmetic Surgery - Probity - PPDS	Richmond Hill	Ontario
Canada	Enverus Medical Research - Probity - PPDS	Surrey	British Columbia
Canada	Dermatology on Bloor	Toronto	Ontario
Canada	Toronto Dermatology Center	Toronto	Ontario
Croatia	Specijalna bolnica za kozne i reumatske bolesti Naftalan	Ivanic-Grad
Croatia	Klinicki bolnicki centar Zagreb	Zagreb	Grad Zagreb
Croatia	Poliklinika Solmed	Zagreb	Grad Zagreb
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	Praglandia s.r.o.	Praha 5
Germany	Hautarztpraxis Dr. Mihaescu	Augsburg	Bayern
Germany	Fachklinik Bad Bentheim	Bad Bentheim	Niedersachsen
Germany	Hautarztpraxis Mahlow	Blankenfelde-Mahlow	Brandenburg
Germany	Studienzentrum an der Hase GbR	Bramsche	Niedersachsen
Germany	Rosenpark Research	Darmstadt
Germany	ProDerma	Dülmen	Nordrhein-Westfalen
Germany	Mensing Derma Research	Hamburg
Germany	Universitatsklinikum Leipzig	Leipzig	Sachsen
Hungary	AES - DRS - Synexus Gyula - Magyarorszag Egeszsegugyi Szolgaltato Kft	Gyula	Békés
Hungary	AES - DRS - Synexus Zalaegerszeg Magyarország Egészségügyi Kft	Zalaegerszeg	Zala
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie	Czestochowa
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gdansk	Pomorskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia	Pomorskie
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach	Katowice
Poland	Pratia MCM	Kraków
Poland	AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi	Lódz	Lódzkie
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu	Poznan	Wielkopolskie
Poland	Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie	Rzeszów	Podkarpackie
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o	Tarnów
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa	Mazowieckie
Poland	Klinika Ambroziak - ul. Kosiarzy 9A	Warszawa	Mazowieckie
Poland	MICS Centrum Medyczne Warszawa	Warszawa	Mazowieckie
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw	Dolnoslaskie
Poland	Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p	Wroclaw	Dolnoslaskie
Poland	dermMEDICA Sp. z o.o.	Wroclaw
Poland	Przychodnia EuroMediCare, Wroclaw Lowiecka	Wroclaw	Dolnoslaskie
Poland	Wro Medica	Wroclaw	Dolnoslaskie
Spain	Hospital General Universitario Dr. Balmis	Alicante
Spain	C.H. Regional Reina Sofia - PPDS	Córdoba
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Hospital Universitario Virgen Macarena	Sevilla
United States	Great Lakes Research Group - 4497 Sheffield Pl	Bay City	Michigan
United States	University of Texas Health Science Center at Houston	Bellaire	Texas
United States	Dermatology Trial Associates - Bryant	Bryant	Arkansas
United States	DermDox Centers for Dermatology	Camp Hill	Pennsylvania
United States	DS Research	Clarksville	Indiana
United States	Studies in Dermatology, LLC	Cypress	Texas
United States	Wright State Physicians	Fairborn	Ohio
United States	Innovate Research, LLC.	Fort Worth	Texas
United States	First OC Dermatology Research Inc.	Fountain Valley	California
United States	North Texas Center for Clinical Research	Frisco	Texas
United States	Abys New Generation Research	Hialeah	Florida
United States	Encore Medical Research - Hollywood	Hollywood	Florida
United States	Indiana Clinical Research Center	Indianapolis	Indiana
United States	JDR Dermatology Research, LLC	Las Vegas	Nevada
United States	Jubilee Clinical Research	Las Vegas	Nevada
United States	California Allergy and Asthma Medical Group	Los Angeles	California
United States	LA Universal Research Center, Inc.	Los Angeles	California
United States	Metropolis Dermatology - Brentwood L.A.	Los Angeles	California
United States	Dermatology Specialists Research - 3810 Springhurst Blvd	Louisville	Kentucky
United States	Marietta Dermatology & The Skin Cancer Center - Marietta	Marietta	Georgia
United States	Apex Clinical Research Center	Mayfield Heights	Ohio
United States	Velocity Clinical Research	Medford	Oregon
United States	Well Pharma Medical Research Corporation	Miami	Florida
United States	San Marcus Research Clinic Inc	Miami Lakes	Florida
United States	International Clinical Research-Tennessee LLC	Murfreesboro	Tennessee
United States	Sadick Research Group	New York	New York
United States	Saguaro Dermatology Associates, LLC	Phoenix	Arizona
United States	GCP Global Clinical Professionals, LLC	Saint Petersburg	Florida
United States	International Clinical Research US LLC	Sanford	Florida
United States	Clinical Science Institute	Santa Monica	California
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	Premier Clinical Research	Spokane	Washington
United States	DermDox Centers for Dermatology	Sugarloaf	Pennsylvania
United States	Olympian Clinical Research	Tampa	Florida
United States	Revival Research Corporation	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Nektar Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Croatia,  Czechia,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16	The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.	Week 0 and Week 16
Secondary	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	The vIGA-AD scale ranges from 0 to 4, with higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Secondary	Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 75% relative to their baseline score (EASI-75)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Secondary	Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 90% relative to their baseline score (EASI-90)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Secondary	Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 50% relative to their baseline score (EASI-50)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Secondary	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	The itch NRS goes from 0 to 10, with higher score indicating more severe itch.	Week 0 and Week 16
Secondary	Proportion of patients at week 16 achieving a SCORing Atopic Dermatitis Index (SCORAD) reduction of 75% from their baseline value	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Secondary	Proportion of patients at week 16 achieving a SCORAD reduction of 50% from their baseline value	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Secondary	Mean change from baseline over the period between week 0 and week 54 in Eczema Area and Severity Index (EASI)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	From Week 0 through Week 54
Secondary	Mean percent change from baseline over the period between week 0 and week 54 in Eczema Area and Severity Index (EASI)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	From Week 0 through Week 54
Secondary	Mean change from baseline over the period between week 0 and week 54 in SCORAD	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.	From Week 0 through Week 54
Secondary	Mean percent change from baseline over the period between week 0 and week 54 in SCORAD	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.	From Week 0 through Week 54
Secondary	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
Secondary	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
Secondary	Rezpegaldesleukin plasma concentration assessed throughout the study		Through end of study (week 54)
Secondary	Incidence of Serious Adverse Events (SAEs)		Through end of study (week 54)
Secondary	Incidence of Treatment Emergent Adverse Events (TEAEs)		Through end of study (week 54)