Clinical trial • Phase II • Dermatology|Immunology

Rezpegaldesleukin for Atopic dermatitis

Phase II trial of Rezpegaldesleukin for Atopic dermatitis.

Overview

Trial Therapeutic Area
Dermatology|Immunology
Trial Disease
Atopic dermatitis
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
29-11-2023
First CTIS Authorization Date
16-04-2024

Trial design

Randomised, placebo: sodium chloride 0.9% solution (placebo); dose and schedule not specified in the record-controlled Phase II trial in Croatia, Hungary, Czechia and others.

Randomised
Yes
Comparator
Placebo: Sodium Chloride 0.9% solution (placebo); dose and schedule not specified in the record
Target Sample Size
189
Trial Duration For Participant
728

Eligibility

Recruits 189 Vulnerable population selected. Participants must "Provide written, informed consent"; legal age of consent rule: "In some jurisdictions, the legal age of consent for study participation is greater than 18 years. For sites in such jurisdictions, the legal age of consent will be used as the lower limit of the age range for this criterion." Specific informed consent forms exist for pregnant participants and pregnant partners and language-specific ICFs are provided..

Pregnancy Exclusion
Provide written, informed consent to participate in the study and follow the study procedures, including compliance with the use of highly effective contraceptives.
Vulnerable Population
Vulnerable population selected. Participants must "Provide written, informed consent"; legal age of consent rule: "In some jurisdictions, the legal age of consent for study participation is greater than 18 years. For sites in such jurisdictions, the legal age of consent will be used as the lower limit of the age range for this criterion." Specific informed consent forms exist for pregnant participants and pregnant partners and language-specific ICFs are provided.

Inclusion criteria

  • {"criterion_text":"- Provide written, informed consent to participate in the study and follow the study procedures, including compliance with the use of highly effective contraceptives.\n- Male or female patients, at least 18 years of age, inclusive, on the day of signing the informed consent form. Note: In some jurisdictions, the legal age of consent for study participation is greater than 18 years. For sites in such jurisdictions, the legal age of consent will be used as the lower limit of the age range for this criterion.\n- Present with a diagnosis of AD at least 12 months prior to screening (Visit 1), as defined by the American Academy of Dermatology “Guidelines of care for the management of atopic dermatitis: Section 1. Diagnosis and assessment of atopic dermatitis” (Eichenfield, 2014)\n- EASI ≥ 16.0 at screening (Visit 1) and randomization (Visit 2).\n- vIGA-AD score ≥ 3 at screening (Visit 1) and randomization (Visit 2).\n- ≥ 10% of BSA involvement at screening (Visit 1) and randomization (Visit 2).\n- Are candidates for systemic therapy and have history, documented by a physician and/or the Investigator, of inadequate response to existing topical medications within 6 months preceding screening (Visit 1), or history of intolerance to topical therapy as defined by at least 1 of the following:\n- Inability to achieve good disease control defined as mild disease or better (eg, vIGA-AD ≤ 2) after use of at least a medium potency TCS for at least 4 weeks, or for the maximum duration recommended by the product prescribing information, eg, 14 days for super potent TCS, whichever is shorter.\n- Note: For the purpose of this criterion, a TCS may be used with or without TCI to address areas of disease.\n- Note: Failing a nonbiologic systemic therapy intended to treat AD,eg, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, or other small molecules, within 6 months before screening (Visit 1) will be considered a surrogate for inadequate response to existing topical medications.\n- A history of clinically significant adverse reactions with the use of TCS, eg, skin atrophy, allergic reaction, or systemic effects that, in the opinion of the Investigator, outweigh the benefits of retreatment."}

Exclusion criteria

  • {"criterion_text":"- Full exclusion criteria are provided in Protocol Section 4.2.\n- Are currently experiencing or have a history of concomitant skin conditions other than AD (e.g., psoriasis or cutaneous lupus), that, in the opinion of the Investigator, would interfere with assessments or interpretation of the effect of study intervention on AD.\n- Are currently experiencing a skin infection in the area affected by the patient’s AD that requires treatment with, or is currently being treated with, topical antimicrobial therapy.\n- Note: Patients who are not eligible (screen fail) due to this criterion should not be rescreened until at least 4 weeks after screen failure and at least 2 weeks after resolution of the infection.\n- History of chronic idiopathic urticaria at any time or urticaria from other causes within 4 weeks prior to randomization.\n- Have a history of TCS use suggestive of a high risk for TCS withdrawal (e.g., a history of prolonged or frequent use of moderate- to high-potency TCS, especially on the face [Hajar, 2015]), such that, in the opinion of the Investigator, the patient will be unable to withdraw and abstain from TCS for several weeks during the study.\n- Have received any of the following treatments at any time before Visit 1: a) aldesleukin b) investigational IL-2 analog c) oral Janus kinase (JAK) inhibitor for any indication, including, but not limited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, and ruxolitinib, whether marketed or investigational d) systemic immune-modulating biologic therapy (including, but not limited to, dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, etc.) whether marketed or investigational.\n- Have received any of the following therapies during the specified time period (“washout”) or are anticipated to require any of these therapies during the study: Table is provided in Protocol Section 4.2.\n- Are unstable with respect to use of chronic treatments (prescription or over the counter) to improve sleep: a) Have started or restarted using a sleep medication during the 2 weeks before the day of the first dose of study intervention b) Have changed the dose of a sleep medication during the 2 weeks before the day of the first dose of study intervention, or c) Are likely to need to start or change the dose of sleep medication during this study, in the opinion of the Investigator.\n- Note: Individuals on a stable dose of sleep medication at screening may be eligible to be enrolled if other study entry criteria are met, but such individuals should remain on the stable dose throughout the study unless, in the Investigator’s opinion, the dose should be changed or stopped to address a safety concern.\n- Have a current or recent acute, active infection. For at least 30 days prior to screening (Visit 1) and up to the Randomization Visit (Visit 2), patients must have no symptoms or signs of confirmed or suspected infection, and must have completed any appropriate anti-infective treatment.\n- Note: Patients who have an oral, upper respiratory, or vaginal candida infection and who are being treated only symptomatically and not requiring systemic anti infectives may be considered for enrollment if other study eligibility criteria are met.\n- Enrollment of patients with other uncomplicated local infections should be discussed with the Sponsor’s designated Medical Monitor.\n- Have had any of the following types of infection within 12 weeks prior to the Screening Visit (Visit 1) or develops any of these infections before the Randomization Visit (Visit 2): a) serious (requiring hospitalization, or intravenous or equivalent oral antibiotic treatment, or both) b) opportunistic (as defined in Winthrop, 2015) c) Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer) d) Recurring (including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis).\n- Have any of the following specific abnormalities on screening laboratory tests: a) serum creatinine, alanine transaminase (ALT), or aspartate transaminase (AST) > 2 × upper limit of normal (ULN).\n- Alkaline phosphatase (ALP) ≥ 2 × ULN.\n- Total bilirubin level (TBL) ≥ 1.5 × ULN.\n- Hemoglobin < 10.0 g/dL.\n- Eosinophilia (absolute eosinophil count) > 1000 cells/μL.\n- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] Creatinine Equation).\n- Have other laboratory test results at screening (Visit 1) which are outside the normal reference range for the population or study site and, in the opinion of the Investigator, indicate unacceptable risk for the patient’s safety in the study.\n- 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 sucessfully treated with no evidence of metastatic disease for 3 years or cervical carcinoma in situ that has been sucessfully treated, with no evidence of recurrence within the 3 years prior to randomization).\n- Have a history of any of the following within 12 months before the Screening Visit (Visit 1): a) myocardial infarction b) unstable ischemic heart disease c) cerebrovascular accident d) stroke e) New York Heart Association Stage III or IV heart failure."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Mean percent change in EASI from baseline at Week 16","definition_or_measurement_approach":"Percent change from baseline in EASI score assessed at Week 16"}

Secondary endpoints

  • {"endpoint_text":"- Proportion of patients from baseline at Week 16 achieving •\tvIGA AD of 0 or 1 and at least a 2-point reduction. •\tEASI-75 •\tEASI 90 •\tEASI-50 •\t≥ 4-point improvement from baseline in Itch NRS in the subset of patients with ≥ 4-point Itch NRS at baseline. •\tSCORAD-75 •\tSCORAD-50","definition_or_measurement_approach":"Proportion of patients achieving the listed categorical endpoints (vIGA-AD, EASI responses, Itch NRS improvement, SCORAD responses) at Week 16 compared with baseline"}
  • {"endpoint_text":"- Mean change from baseline over the period between Week 0 and Week 104 in •\tEASI •\tSCORAD •\tBSA involvement","definition_or_measurement_approach":"Mean absolute change from baseline in EASI, SCORAD and BSA involvement measured across Week 0 to Week 104"}
  • {"endpoint_text":"- Mean percent change from baseline over the period between Week 0 and Week 104 in •\tEASI •\tSCORAD •\tBSA involvement","definition_or_measurement_approach":"Mean percent change from baseline in EASI, SCORAD and BSA involvement assessed over Week 0 to Week 104"}
  • {"endpoint_text":"- In addition, all of the above efficacy assessments will be further evaluated at other time points during induction therapy, maintenance therapy, and follow-up - Rezpegaldesleukin plasma concentrations at various time points assessed throughout the study. - Incidence of •\tSerious adverse events (SAEs) •\tTreatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":"PK: rezpegaldesleukin plasma concentrations measured at scheduled time points. Safety: incidence and categorization of SAEs and TEAEs as recorded during the study period"}

Recruitment

Digital Remote Recruitment
True, advertising materials include banner ads and patient FAQs (Germany) and electronic patient-facing materials; ePRO/eClinRO vendor support (Signant Health) is in place for remote data capture
Planned Sample Size
189
Recruitment Window Months
32
Consent Approach
Written informed consent is required from each participant ('Provide written, informed consent to participate in the study and follow the study procedures'). Legal age of consent applies: participants must be at least 18 years old, but in jurisdictions with a higher legal age the local legal age will be used. Multiple language ICFs are provided (documents for DE, ENG, ES, HR/Croatian, HU/Hungarian, PL/Polish, BG/Bulgarian, CZ/Czech). Specific ICFs exist for pregnant participants, pregnant partners and newborns where applicable.

Methods

  • Doctor-to-Doctor letters (country-specific K1/K2 recruitment documents) - present for multiple countries (e.g., Croatia, Hungary, Czechia, Spain, Bulgaria, Germany, Poland) to inform clinicians about the study and referral pathways
  • Country-specific recruitment arrangements documents (K1/K2) describing local recruitment procedures (documents exist for Croatia, Hungary, Czechia, Spain, Bulgaria, Germany, Poland)
  • Advertising materials (e.g., Banner) and Patient FAQ (Germany) - advertised patient-facing materials for recruitment (document: K2_Avertising-material_Banner_DE and PatientFAQ)
  • Study information and informed consent materials (ICFs and patient information sheets) in multiple languages provided to potential participants

Geography

Total Number Of Sites
63
Total Number Of Participants
366

Croatia

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
259
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
KBC Zagreb
Department Name
Department of Dermatology
Contact Person Name
Suzana Ljubojevic Hadzavdic
Contact Person Email
suzana.ljubojevic@gmail.com
Site Name
Poliklinika Solmed d.o.o.
Department Name
Department of Dermatovenerology
Contact Person Name
Iva Blajic
Contact Person Email
iva.blajic@solmed-clinic.com
Site Name
NAFTALAN specijalna bolnica za medicinsku rehabilitaciju
Department Name
Department of dermatology and venerology
Contact Person Name
Gordana Krnjevic Pezic

Hungary

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
28-11-2024
Processing Time Days
254
Number Of Sites
2
Number Of Participants
25

Sites

Site Name
SYNEXUS Magyarorszag Kft.
Contact Person Name
Anikó Fekete
Contact Person Email
aniko.fekete@globalaes.com
Site Name
SYNEXUS Magyarorszag Kft.
Contact Person Name
Mariann Tóth
Contact Person Email
mariann.toth@globalaes.com

Czechia

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
28-02-2025
Processing Time Days
347
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Praglandia s.r.o.
Contact Person Name
Andrea Vocilková
Contact Person Email
a.voc@praglandia.cz
Site Name
Pratia Brno s.r.o.
Contact Person Name
Simona Bukalová
Contact Person Email
sbukalova@volny.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Dermatovenerologická klinika
Contact Person Name
Spyridon Gkalpakiotis
Contact Person Email
Spyridon.Gkalpakiotis@fnkv.cz
Site Name
Pratia Pardubice a.s.
Contact Person Name
Andrea Bartlová

Spain

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
17-02-2025
Processing Time Days
336
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Dermatology
Contact Person Name
Trinidad Montero Vilchez
Contact Person Email
tmonterov@gmail.com
Site Name
Hospital De Manises
Department Name
Dermatology
Contact Person Name
Antonio Martorell Calatayud
Contact Person Email
antmarto@hotmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Dermatology
Contact Person Name
Lara Ferrándiz Pulido
Contact Person Email
lferrandiz.eecc@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Dermatology
Contact Person Name
Juan Ruano Ruiz
Contact Person Email
juanruanoruiz@mac.com
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Dermatology
Contact Person Name
Servando Marron Moya
Contact Person Email
semarron@aedv.es
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Dermatology
Contact Person Name
Juan Francisco Silvestre Salvador
Contact Person Email
silvestre.jfr@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
575
Number Of Sites
9
Number Of Participants
51

Sites

Site Name
Dkc Fokus-5 Lzip OOD
Department Name
Dermato-venerology
Contact Person Name
Grisha Mateev
Contact Person Email
grisha_mateev@yahoo.com
Site Name
Medical Center Hera EOOD
Department Name
Dermato-venerology
Contact Person Name
Maria Ratkova
Contact Person Email
maria.ratkova@heraclinics.com
Site Name
Diagnostic-Consultative Center Alexandrovska EOOD
Department Name
Dermato-venerology
Contact Person Name
Petyo Brezoev
Contact Person Email
brezoev@gmail.com
Site Name
UNIMED Medical Center EOOD
Department Name
Dermato-venerology
Contact Person Name
Marina Sankeva
Contact Person Email
dr_sankeva@abv.bg
Site Name
Medical Center Medconsult Pleven OOD
Department Name
Dermato-venerology
Contact Person Name
Kamelia Vekovska
Contact Person Email
kvekovska_medconsult@abv.bg
Site Name
Asclepius Medical Center OOD
Department Name
Dermato-venerology
Contact Person Name
Boyka Stoyanova
Contact Person Email
dr.boyka.stoyanova@gmail.com
Site Name
Medical Center Medconsult Pleven OOD
Department Name
Dermato-venerology
Contact Person Name
Krasimira Vasileva
Contact Person Email
mclovech@abv.bg
Site Name
Medical Center Excelsior OOD
Department Name
Internal Diseases, Clinical Allergology
Contact Person Name
Todor Popov
Contact Person Email
ted.popov@gmail.com
Site Name
Diagnostic And Consulting Center XXVIII-Sofia EOOD
Department Name
Dermato-venerology
Contact Person Name
Katya Zaharieva
Contact Person Email
dr.k.zaharieva@abv.bg

Germany

Earliest CTIS Part Ii Submission Date
11-01-2024
Latest Decision Or Authorization Date
30-10-2025
Processing Time Days
658
Number Of Sites
12
Number Of Participants
65

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Department of Dermatology and Allergy
Contact Person Name
Petra Staubach-Renz
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Fachklinik Bad Bentheim Klinisches Studienzentrum
Contact Person Name
Athanasios Tsianakas
Contact Person Email
a.tsianakas@fk-bentheim.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Jan Simon
Site Name
Rosenpark Research GmbH
Department Name
Rosenpark Research GmbH
Contact Person Name
Oliver Weirich
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Institut für Entzündungsmedizin
Contact Person Name
Diamant Thaci
Contact Person Email
Diamant.Thaci@uksh.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik für Dermatologie und Allergologie
Contact Person Name
Teodora Pumnea
Site Name
Goethe University Frankfurt
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Andreas Pinter
Contact Person Email
andreas.pinter@kgu.de
Site Name
Hautarztpraxis Dr. Mihaescu
Department Name
Hautarztpraxis Dr. Mihaescu
Contact Person Name
Virgil-Oreste Mihaescu
Contact Person Email
info@dr-mihaescu.de
Site Name
ISA Interdisciplinary Study Association GmbH
Department Name
ISA - Interdisciplinary Study Association GmbH
Contact Person Name
Margrit Simon
Contact Person Email
msimon@isa-research.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hautklinik
Contact Person Name
Michael Sticherling
Site Name
Universitaetsklinikum Augsburg
Department Name
Klinik für Dermatologie und Allergologie
Contact Person Name
Andreas Wollenberg
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Dematologie, Venerologie und Allergologie
Contact Person Name
Margitta Worm
Contact Person Email
margitta.worm@charite.de

Poland

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
30-10-2025
Processing Time Days
591
Number Of Sites
27
Number Of Participants
150

Sites

Site Name
Royalderm Agnieszka Nawrocka
Contact Person Name
Witold Owczarek
Contact Person Email
witold.owczarek@dermedicus.pl
Site Name
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
Contact Person Name
Aleksandra Lesiak
Contact Person Email
lesiak_ola@interia.pl
Site Name
EMC Instytut Medyczny S.A.
Department Name
Penta Hospitals Przychodnie, Wrocław Wejherowska
Contact Person Name
Anna Luty
Contact Person Email
lfanna1@gmail.com
Site Name
Diamond Clinic Sp. z o.o.
Contact Person Name
Barbara Rewerska
Contact Person Email
p.rewerski@gmail.com
Site Name
Klinika Ambroziak Sp. z o.o.
Department Name
Dermatologia
Contact Person Name
Justyna Skibińska
Site Name
Dermmedica Sp. z o.o.
Contact Person Name
Jolanta Węgłowska
Contact Person Email
jolaweglowska@tlen.pl
Site Name
Synexus Polska Sp. z o.o.
Contact Person Name
Rafał Sługocki
Contact Person Email
rafal.slugocki@globalaes.com
Site Name
Synexus Polska Sp. z o.o.
Contact Person Name
Tomasz Kołodziej
Contact Person Email
tomasz.kolodziej@globalaes.com
Site Name
Synexus Polska Sp. z o.o.
Contact Person Name
Anna Janowicz
Contact Person Email
anna.janowicz@synexus.com
Site Name
Synexus Polska Sp. z o.o.
Contact Person Name
Joanna Renczyńska-Matysko
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Contact Person Name
Grażyna Pulka
Contact Person Email
pulkaallmed@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
Klinika Dermatologii i Dermatologii Onkologicznej
Contact Person Name
Adam Reich
Contact Person Email
adamandrzejreich@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
Centrum Medyczne Warszawa
Contact Person Name
Joanna Kolinek
Site Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Contact Person Name
Jacek Szepietowski
Site Name
Synexus Polska Sp. z o.o.
Contact Person Name
Joanna Sieniawska
Site Name
Synexus Polska Sp. z o.o.
Contact Person Name
Karolina Antkowiak-Piątyszek
Site Name
Osrodek Badan Klinicznych Bd Research Sp. z o.o.
Contact Person Name
Jakub Baszczyński
Site Name
Synexus Polska Sp. z o.o.
Contact Person Name
Marcin Zakrzewski
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Tadeusz Debniak
Contact Person Email
debniak@twojaprzychodnia.com
Site Name
Synexus Polska Sp. z o.o.
Contact Person Name
Ryszard Galus
Contact Person Email
Ryszard.galus@globalaes.com
Site Name
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.
Contact Person Name
Bernadetta Majorek-Olechowska
Contact Person Email
bernadettaolechowska@gmail.com
Site Name
Clinical Research Group Sp. z o.o.
Contact Person Name
Kamila Padlewska
Contact Person Email
kamila@padlewska.com
Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Contact Person Name
Dorota Kołodziejczyk
Contact Person Email
dkolodziejczyk@pratia.pl
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Contact Person Name
Aleksandra Okuniewska
Contact Person Email
a.okuniewska@gumed.edu.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Dermatologii
Contact Person Name
Irena Walecka-Herniczek
Contact Person Email
irena.walecka@cskmswia.gov.pl
Site Name
Wromedica I Bielicka A Strzalkowska s.c.
Contact Person Name
Wojciech Baran
Contact Person Email
wojciech.baran@umed.wroc.pl
Site Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Contact Person Name
Malgorzata Dyczek

Sponsor

Primary sponsor

Full Name
Nektar Therapeutics
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
sponsor duties codes:1,12,13,2,5,6,8,9
Name
Pharmaceutical Product Development LLC
Responsibilities
central lab/site services (code:4)
Name
WCG Clinical Inc.
Responsibilities
Investigator Rater Training
Name
4g Clinical LLC
Responsibilities
operational support (sponsor duties code:3)

Third parties

  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes:1,12,13,2,5,6,8,9","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Investigator Rater Training","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"National Jewish Health","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"Ancillary lab; code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"Investigator Meeting","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Inivata Limited","duties_or_roles":"Ancillary lab; code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel & Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"ePRO and eClinRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
NKTR-358
Active Substance
Rezpegaldesleukin
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection
Authorisation Status
Investigational medicinal product (MIA number IMP00065/00001)
Investigational Product Name
Sodium Chloride 0.9% solution
Modality
Other

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