Clinical trial • Immunology|Dermatology

DUPILUMAB for Chronic pruritus of unknown origin (CPUO)

Clinical trial of DUPILUMAB for Chronic pruritus of unknown origin (CPUO).

Overview

Trial Therapeutic Area: Immunology|Dermatology
Trial Disease: Chronic pruritus of unknown origin (CPUO)
Drug Modality: Monoclonal antibody|Other

Key dates

Initial CTIS Submission Date: 22-12-2023
First CTIS Authorization Date: 23-02-2024

Trial design

Randomised, matched placebo to test (placebo arm). dose and schedule not specified in available ctis metadata.-controlled trial across 32 sites in Poland, Italy, Spain and others.

Randomised: Yes
Comparator: Matched placebo to test (placebo arm). Dose and schedule not specified in available CTIS metadata.
Target Sample Size: 120
Trial Duration For Participant: 168

Eligibility

Recruits 120 No vulnerable populations selected (isVulnerablePopulationSelected=false). Participants must be adults (18 or the legal age of consent in the jurisdiction) up to 90 years of age and must sign informed consent themselves prior to participation..

Vulnerable Population: No vulnerable populations selected (isVulnerablePopulationSelected=false). Participants must be adults (18 or the legal age of consent in the jurisdiction) up to 90 years of age and must sign informed consent themselves prior to participation.

Inclusion criteria

{"criterion_text":"- Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent."}
{"criterion_text":"- Participants with chronic pruritus for at least 6 months before the screening visit."}
{"criterion_text":"- Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs)."}
{"criterion_text":"- Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk."}
{"criterion_text":"- History of insufficient control of the chronic pruritus with prior treatment."}
{"criterion_text":"- Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency)."}
{"criterion_text":"- Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient global impression of severity (PGIS) of pruritus scored “severe” at screening."}
{"criterion_text":"- Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS."}
{"criterion_text":"- Participants scored “severe” in the PGIS of pruritus on Day 1."}

Exclusion criteria

{"criterion_text":"- Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the patient’s participation in the study."}
{"criterion_text":"- Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent."}
{"criterion_text":"- Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit."}
{"criterion_text":"- HIV infection."}
{"criterion_text":"- Severe renal failure (dialysis)."}
{"criterion_text":"- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit"}
{"criterion_text":"- Known or suspected immunodeficiency."}
{"criterion_text":"- Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin."}
{"criterion_text":"- History of hypersensitivity or intolerance to non-sedative antihistamines."}
{"criterion_text":"- Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab."}

Endpoints

Primary endpoints

{"endpoint_text":"- Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24","definition_or_measurement_approach":"Measured as proportion of participants achieving ≥4-point reduction in weekly average of daily WI-NRS from baseline to Week 24 (WI-NRS scale 0–10)."}
{"endpoint_text":"- Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12","definition_or_measurement_approach":"Measured as proportion of participants achieving ≥4-point reduction in weekly average of daily WI-NRS from baseline to Week 12 (WI-NRS scale 0–10)."}

Secondary endpoints

{"endpoint_text":"- Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12","definition_or_measurement_approach":"Proportion achieving ≥4-point reduction in weekly average of daily WI-NRS by Week 12."}
{"endpoint_text":"- Study A: Proportion of participants who scored “none” or “mild” in Patient Global Impression of Severity (PGIS) of pruritus at Week 24","definition_or_measurement_approach":"Proportion with PGIS category 'none' or 'mild' at Week 24 (PGIS patient-reported severity)."}
{"endpoint_text":"- Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 24","definition_or_measurement_approach":"Proportion over time up to Week 24 meeting ≥4-point weekly average WI-NRS reduction."}
{"endpoint_text":"- Study A: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24","definition_or_measurement_approach":"Time-to-event measure: time from baseline to first occurrence of ≥4-point reduction in WI-NRS, censored at Week 24."}
{"endpoint_text":"- Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24","definition_or_measurement_approach":"Mean absolute change in weekly average daily WI-NRS from baseline to Week 24."}
{"endpoint_text":"- Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24","definition_or_measurement_approach":"Percent change in weekly average daily WI-NRS from baseline to Week 24."}
{"endpoint_text":"- Study A: Proportion of participants who scored “none” or “mild” in PGIS of pruritus at Week 12","definition_or_measurement_approach":"Proportion with PGIS 'none' or 'mild' at Week 12."}
{"endpoint_text":"- Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12","definition_or_measurement_approach":"Mean absolute change in weekly average WI-NRS from baseline to Week 12."}
{"endpoint_text":"- Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12","definition_or_measurement_approach":"Percent change in weekly average WI-NRS from baseline to Week 12."}
{"endpoint_text":"- Study A: Absolute change from baseline in weekly average of daily sleep disturbances numerical rating scale (NRS) at Week 24","definition_or_measurement_approach":"Mean absolute change in weekly average daily sleep disturbance NRS from baseline to Week 24."}
{"endpoint_text":"- Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 24","definition_or_measurement_approach":"Percent change in weekly average daily sleep disturbance NRS from baseline to Week 24."}
{"endpoint_text":"- Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 24","definition_or_measurement_approach":"Mean change in DLQI score from baseline to Week 24."}
{"endpoint_text":"- Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 24","definition_or_measurement_approach":"Mean change in ItchyQoL score from baseline to Week 24."}
{"endpoint_text":"- Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 24","definition_or_measurement_approach":"Mean change in HADS total score from baseline to Week 24."}
{"endpoint_text":"- Study A: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 12","definition_or_measurement_approach":"Mean absolute change in weekly average daily sleep disturbance NRS from baseline to Week 12."}
{"endpoint_text":"- Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 12","definition_or_measurement_approach":"Percent change in weekly average daily sleep disturbance NRS from baseline to Week 12."}
{"endpoint_text":"- Study A: Change from baseline in DLQI score at Week 12","definition_or_measurement_approach":"Mean change in DLQI score from baseline to Week 12."}
{"endpoint_text":"- Study A: Change from baseline in the ItchyQoL score at Week 12","definition_or_measurement_approach":"Mean change in ItchyQoL score from baseline to Week 12."}
{"endpoint_text":"- Study A: Change from baseline in HADS total score at Week 12","definition_or_measurement_approach":"Mean change in HADS total score from baseline to Week 12."}
{"endpoint_text":"- Study A: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through end of study (EOS)","definition_or_measurement_approach":"Proportion of participants with TEAEs or SAEs from baseline through EOS; safety monitoring across study."}
{"endpoint_text":"- Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab","definition_or_measurement_approach":"Incidence (frequency) of treatment-emergent anti-drug antibodies to dupilumab measured during treatment."}
{"endpoint_text":"- Study B: Proportion of participants who scored “none” or “mild” in PGIS of pruritus at Week 24","definition_or_measurement_approach":"Proportion with PGIS 'none' or 'mild' at Week 24 in Study B."}
{"endpoint_text":"- Study B: Proportion of participants who scored “none” or “mild” in PGIS of pruritus at Week 12","definition_or_measurement_approach":"Proportion with PGIS 'none' or 'mild' at Week 12 in Study B."}
{"endpoint_text":"- Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12","definition_or_measurement_approach":"Mean absolute change in weekly average WI-NRS from baseline to Week 12 (Study B)."}
{"endpoint_text":"- Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12","definition_or_measurement_approach":"Percent change in weekly average WI-NRS from baseline to Week 12 (Study B)."}
{"endpoint_text":"- Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 24","definition_or_measurement_approach":"Mean absolute change in weekly average WI-NRS from baseline to Week 24 (Study B)."}
{"endpoint_text":"- Study B: Percentage change from baseline in weekly average of daily WI-NRS at Week 24","definition_or_measurement_approach":"Percent change in weekly average WI-NRS from baseline to Week 24 (Study B)."}
{"endpoint_text":"- Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline, sustained from Week 19 through Week 24","definition_or_measurement_approach":"Proportion achieving ≥4-point reduction in weekly average daily WI-NRS sustained from Week 19 through Week 24."}
{"endpoint_text":"- Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 24","definition_or_measurement_approach":"Proportion achieving ≥5-point reduction in weekly average WI-NRS from baseline to Week 24."}
{"endpoint_text":"- Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24","definition_or_measurement_approach":"Proportion achieving ≥4-point reduction in weekly average WI-NRS from baseline to Week 24 (Study B)."}
{"endpoint_text":"- Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 24","definition_or_measurement_approach":"Proportion with weekly average daily WI-NRS <2 at Week 24."}
{"endpoint_text":"- Study B: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24","definition_or_measurement_approach":"Time to first occurrence of ≥4-point WI-NRS reduction up to Week 24 (Study B)."}
{"endpoint_text":"- Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 12","definition_or_measurement_approach":"Proportion achieving ≥5-point reduction in weekly average WI-NRS from baseline to Week 12."}
{"endpoint_text":"- Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 12","definition_or_measurement_approach":"Proportion with weekly average daily WI-NRS <2 at Week 12 (Study B)."}
{"endpoint_text":"- Study B: Absolute change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24","definition_or_measurement_approach":"Mean absolute change in weekly average itch-related sleep disturbance NRS at Weeks 12 and 24."}
{"endpoint_text":"- Study B: Percent change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24","definition_or_measurement_approach":"Percent change in weekly average itch-related sleep disturbance NRS at Weeks 12 and 24."}
{"endpoint_text":"- Study B: Change from baseline in DLQI score at Week 12 and Week 24","definition_or_measurement_approach":"Mean change in DLQI score from baseline at Weeks 12 and 24."}
{"endpoint_text":"- Study B: Change from baseline in the ItchyQoL score at Week 12 and Week 24","definition_or_measurement_approach":"Mean change in ItchyQoL score from baseline at Weeks 12 and 24."}
{"endpoint_text":"- Study B: Change from baseline in HADS total score at Week 12 and Week 24","definition_or_measurement_approach":"Mean change in HADS total score from baseline at Weeks 12 and 24."}
{"endpoint_text":"- Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS","definition_or_measurement_approach":"Proportion of participants with TEAEs or SAEs from baseline through EOS (safety endpoint)."}
{"endpoint_text":"- Study B: Incidence of treatment-emergent ADA against dupilumab","definition_or_measurement_approach":"Incidence of treatment-emergent anti-drug antibodies to dupilumab during treatment."}

Recruitment

Digital Remote Recruitment: Yes
Planned Sample Size: 120
Recruitment Window Months: 44
Consent Approach: Informed consent obtained from participant (participants must be 18 or legal age of consent). Subject information and informed consent forms (L1-sis-icf) are provided in multiple languages (English, Italian, Spanish, French, Polish, Hungarian, German as per published documents). Partner/pregnancy information documents are also available in some countries.

Methods

Doctor-to-doctor letters and site-to-physician communications (documents present for multiple countries: IT, ES, DE, HU, PL, FR).
Patient brochure / leaflet and patient-facing materials (languages and country-specific brochures present for IT, ES, FR, HU, DE, PL).
Social media post(s) (document titled social-media-post-it indicating social media use in Italy).
Webpage / sponsor study webpage materials and web scripts (webpage/web-script documents present for ES, HU, DE and country-specific webpages).
Posters (Spain patient recruitment poster present).
Site-level web scripts / phone scripts for site staff (documents labelled web-script present).

Geography

Total Number Of Sites: 32
Total Number Of Participants: 172

Poland

Earliest CTIS Part Ii Submission Date: 23-01-2024
Latest Decision Or Authorization Date: 29-02-2024
Processing Time Days: 37
Number Of Sites: 5
Number Of Participants: 32

Sites

Site Name: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Contact Person Name: Jacek Szepietowski
Contact Person Email: jacek.szepietowski@umed.wroc.pl

Site Name: Mtz Clinical Research Powered By Pratia
Contact Person Name: Agnieszka Kardynal
Contact Person Email: agnieszka.kardynal@pratia.com

Site Name: Dermmedica Sp. z o.o.
Contact Person Name: Jolanta Weglowska
Contact Person Email: jolaweglowska@tlen.pl

Site Name: Centrum Medyczne All-Med Badania Kliniczne
Contact Person Name: Grazyna Pulka
Contact Person Email: pulkaallmed@gmail.com

Site Name: Clinical Research Group Sp. z o.o.
Department Name: ul. Sokolowska 9/U-2
Contact Person Name: Kamila Padlewska
Contact Person Email: kamila@padlewska.com

Italy

Earliest CTIS Part Ii Submission Date: 23-01-2024
Latest Decision Or Authorization Date: 26-02-2024
Processing Time Days: 34
Number Of Sites: 7
Number Of Participants: 37

Sites

Site Name: Humanitas Research Hospital
Department Name: UO Dermatologia
Contact Person Name: Antonio Costanzo
Contact Person Email: antonio.costanzo@hunimed.eu

Site Name: Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name: UOC Dermatologia Clinica
Contact Person Name: Maddalena Napolitano
Contact Person Email: maddalena.napolitano@unina.it

Site Name: Azienda Ospedaliero Universitaria Delle Marche
Department Name: SOD Clinica Dermatologica
Contact Person Name: Oriana Simonetti
Contact Person Email: oriana.simonetti@ospedaliriuniti.marche.it

Site Name: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name: SC DERMATOLOGIA
Contact Person Name: Silvia Ferrucci
Contact Person Email: silviaferrucci@hotmail.com

Site Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name: UOC Dermatologia
Contact Person Name: Ketty Peris
Contact Person Email: ketty.peris@unicatt.it

Site Name: Azienda USL Toscana Centro
Department Name: Department of Health Sciences Section of Dermatology
Contact Person Name: Emiliano Antiga
Contact Person Email: emiliano.antiga@unifi.it

Site Name: University Hospital Of Ferrara
Department Name: U.O. Dermatology
Contact Person Name: Alessandro Borghi
Contact Person Email: alessandro.borghi@unife.it

Spain

Earliest CTIS Part Ii Submission Date: 23-01-2024
Latest Decision Or Authorization Date: 23-02-2024
Processing Time Days: 31
Number Of Sites: 5
Number Of Participants: 34

Sites

Site Name: Hospital Del Mar
Department Name: Dermathology unit
Contact Person Name: Marta Ferran Farres
Contact Person Email: mferran@psmar.cat

Site Name: Hospital General Universitario Dr. Balmis
Department Name: Dermathology unit
Contact Person Name: Juan Francisco Silvestre Salvador
Contact Person Email: silvestre.jfr@gmail.com

Site Name: Hospital De La Santa Creu I Sant Pau
Department Name: Dermathology unit
Contact Person Name: Esther Serra-Baldrich
Contact Person Email: ESerra@santpau.cat

Site Name: Complexo Hospitalario Universitario De Pontevedra
Department Name: Dermathology unit
Contact Person Name: Maria Teresa Abalde Pintos
Contact Person Email: teresa.abalde.pintos@sergas.es

Site Name: Hospital Universitario Reina Sofia
Department Name: Dermathology unit
Contact Person Name: Juan Alberto Ruano Ruiz
Contact Person Email: juanruanoruiz@mac.com

France

Earliest CTIS Part Ii Submission Date: 28-10-2025
Latest Decision Or Authorization Date: 03-11-2025
Processing Time Days: 6
Number Of Sites: 3
Number Of Participants: 1

Sites

Site Name: Centre Hospitalier Regional Et Universitaire De Brest
Department Name: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan Service de Dermatologie
Contact Person Name: Laurent Misery
Contact Person Email: laurent.misery@chu-brest.fr

Site Name: Courlancy Sante
Department Name: Polyclinique Courlancy Service de Dermatologie
Contact Person Name: Ziad REGUIAI
Contact Person Email: dr-reguiai@orange.fr

Site Name: Centre Hospitalier Universitaire De Nice
Department Name: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet Service de Dermatologie
Contact Person Name: Thierry Passeron
Contact Person Email: passeron.t@chu-nice.fr

Hungary

Earliest CTIS Part Ii Submission Date: 23-01-2024
Latest Decision Or Authorization Date: 23-02-2024
Processing Time Days: 31
Number Of Sites: 7
Number Of Participants: 44

Sites

Site Name: Geomedical Kft.
Contact Person Name: Földes Márta
Contact Person Email: drfoldesmarta@gmail.com

Site Name: Vita Verum Medical Bt.
Department Name: Vita Verum Medical Egészségügyi Szolgáltató Betéti Társaság
Contact Person Name: Viktor Gerzanits
Contact Person Email: gerzanicsviktor75@gmail.com

Site Name: Derma-B Kft.
Contact Person Name: Emese Clemens-Heredi
Contact Person Email: emeseheredi@gmail.com

Site Name: Obudai Egeszsegugyi Centrum Kft.
Contact Person Name: Aniko Fekete
Contact Person Email: aniko.fekete@oec.hu

Site Name: Bekes Varmegyei Koezponti Korhaz
Department Name: Borgyogyaszati Osztaly
Contact Person Name: Ócsai Henriette
Contact Person Email: ocsai.henriette@bmkk.eu

Site Name: University Of Szeged
Department Name: Bőrgyógyászati és Allergológiai Klinika
Contact Person Name: Géza Nagy
Contact Person Email: n.geza@outlook.com

Site Name: Obudai Egeszsegugyi Centrum Kft.
Contact Person Name: Andrea Fay
Contact Person Email: andrea.fay@oec.hu

Germany

Earliest CTIS Part Ii Submission Date: 23-01-2024
Latest Decision Or Authorization Date: 26-02-2024
Processing Time Days: 34
Number Of Sites: 5
Number Of Participants: 24

Sites

Site Name: Goethe University Frankfurt
Department Name: Dermatologie
Contact Person Name: Andreas Pinter
Contact Person Email: andreas.pinter@kgu.de

Site Name: Charite Universitaetsmedizin Berlin KöR
Department Name: Institut fur Allergieforschung (IFA)
Contact Person Name: Martin Metz
Contact Person Email: martin.metz@charite.de

Site Name: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name: Dermatologie, Allergologie
Contact Person Name: Petra Staubach-Renz
Contact Person Email: petra.staubach@unimedizin-mainz.de

Site Name: Thermalsole und Schwefelbad Bentheim GmbH
Department Name: Department of Dermatology
Contact Person Name: Athanasios Tsianakas
Contact Person Email: a.tsianakas@fk-bentheim.de

Site Name: Universitaet Muenster
Department Name: Dermatologie
Contact Person Name: Claudia Zeidler
Contact Person Email: claudia.zeidler@ukmuenster.de

Sponsor

Primary sponsor

Full Name: Sanofi-Aventis Recherche & Developpement
Organisation Type: Pharmaceutical company
Country Of Registered Address: France

Contract research organisations

Name: Endpoint Clinical Inc.
Responsibilities: sponsorDuties codes: [3]

Name: PPD Development LP
Responsibilities: sponsorDuties codes: [4]

Name: Parexel International Services India Private Limited
Responsibilities: sponsorDuties codes: [8]

Name: Pharmaceutical Product Development LLC
Responsibilities: sponsorDuties codes: [4]

Name: PPD International Holdings LLC
Responsibilities: sponsorDuties codes: [4]

Third parties

{"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"Hungary","full_name":"European Pharma Hub Kft.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
{"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
{"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
{"country":"Poland","full_name":"Sanofi-Aventis Sp. z o.o.","duties_or_roles":"sponsorDuties codes: [12]","organisation_type":"Pharmaceutical company"}
{"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
{"country":"India","full_name":"Parexel International Services India Private Limited","duties_or_roles":"sponsorDuties codes: [8]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Regeneron Pharmaceuticals Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: Dupilumab
Active Substance: DUPILUMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS
Route: SUBCUTANEOUS
Maximum Dose: 600 mg (maxDailyDoseAmount)

Investigational Product Name: Matched placebo to test
Modality: Other

Investigational Product Name: LORATADINE
Active Substance: PSEUDOEPHEDRINE HYDROCHLORIDE, LORATADINE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Marketing product entry present (prodAuthStatus=2)

Investigational Product Name: FEXOFENADINE
Active Substance: FEXOFENADINE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Marketing product entry present (prodAuthStatus=2)

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