NCT03749135 (DUPICSU) is a Phase 2 clinical trial of Dupilumab in Chronic Spontaneous Urticaria, sponsored by Charite University, Berlin, Germany.

Who is sponsoring NCT03749135?

NCT03749135 is sponsored by Charite University, Berlin, Germany.

What drugs are being tested in NCT03749135?

Interventions in NCT03749135: Dupilumab, Placebo.

What condition does NCT03749135 study?

NCT03749135 studies Chronic Spontaneous Urticaria, Recurrent Angioedema.

Is NCT03749135 still recruiting?

NCT03749135 is currently completed. Last updated 2 February 2022.

Last reviewed 2022-02-02 · How we verify

NCT03749135: DUPICSU

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dupilumab in Chronic Spontaneous Urticaria

Completed Phase 2 Last updated 2 February 2022

What this trial tests

Phase 2 trial testing Dupilumab in Chronic Spontaneous Urticaria in 72 participants. Completed in 7 July 2021.

Timeline

12 November 2018

Primary endpoint
7 July 2021

7 July 2021

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	72
Start date	12 November 2018
Primary completion	7 July 2021
Estimated completion	7 July 2021
Sites	6 locations across Germany

Drugs / interventions tested

Dupilumab (DUPILUMAB) — full drug profile →
Placebo

Conditions studied

Chronic Spontaneous Urticaria — all drugs for Chronic Spontaneous Urticaria →
Recurrent Angioedema — all drugs for Recurrent Angioedema →

Sponsor

Charite University, Berlin, Germany

Who can join

Adults 18 to 75, any sex, with Chronic Spontaneous Urticaria or Recurrent Angioedema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the efficacy in reducing disease activity and safety of Dupilumab in adult patients with chronic spontaneous urticaria (CSU) who are symptomatic despite H1-antihistamine treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Dupilumab in Inflammatory Skin Diseases: A Systematic Review.
Olbrich H, Sadik CD, Ludwig RJ, Thaçi D, et al · · 2023 · cited 67× · PMID 37189381 · DOI 10.3390/biom13040634
A review of dupilumab in the treatment of atopic diseases.
Thibodeaux Q, Smith MP, Ly K, Beck K, et al · · 2019 · cited 59× · PMID 30785362 · DOI 10.1080/21645515.2019.1582403
A New Generation of Treatments for Itch.
Fowler E, Yosipovitch G. · · 2020 · cited 30× · PMID 31940047 · DOI 10.2340/00015555-3347
Current and emerging treatments for chronic spontaneous urticaria.
Johal KJ, Saini SS. · · 2020 · cited 26× · PMID 31494233 · DOI 10.1016/j.anai.2019.08.465
Novel Approaches in the Inhibition of IgE-Induced Mast Cell Reactivity in Food Allergy.
Tontini C, Bulfone-Paus S. · · 2021 · cited 24× · PMID 34456900 · DOI 10.3389/fimmu.2021.613461
Use of biologics in chronic spontaneous urticaria - beyond omalizumab therapy?
Metz M, Maurer M. · · 2021 · cited 13× · PMID 33615122 · DOI 10.5414/alx02204e
Presence of positive skin prick tests to inhalant allergens and markers of T2 inflammation in subjects with chronic spontaneous urticaria (CSU): a systematic literature review.
Wong MM, Keith PK. · · 2020 · cited 13× · PMID 32944029 · DOI 10.1186/s13223-020-00461-x
Update on the Treatment of Chronic Spontaneous Urticaria.
Kolkhir P, Fok JS, Kocatürk E, Li PH, et al · · 2025 · cited 10× · PMID 40074986 · DOI 10.1007/s40265-025-02170-4

Verify or expand the search:

Other trials of Dupilumab

Trials testing the same drug.

NCT07316114 — A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spont · recruiting
NCT07277322 — Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases · Phase 1, PHASE2 · not yet recruiting
NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
NCT07399067 — A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis · Phase 2 · recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting

Other recruiting trials for Chronic Spontaneous Urticaria

Currently open trials in the same condition.

NCT07316114 — A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spont · recruiting
NCT07358364 — Remibrutinib in Real-world Clinical Practice · recruiting
NCT07358780 — Remibrutinib in Real-world Clinical Practice - a US Sub-study · recruiting
NCT07408219 — A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients · recruiting
NCT07219615 — A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. · Phase 2 · recruiting

Other Charite University, Berlin, Germany trials

Trials by the same sponsor.

NCT07486167 — Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congeni · Phase 1, PHASE2 · not yet recruiting
NCT07476729 — International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) · Phase 3 · not yet recruiting
NCT07503054 — Ovarian Cancer Screening and AI · NA · not yet recruiting
NCT07529197 — Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS · recruiting
NCT07388693 — Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03749135 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Charite University, Berlin, Germany
Last refreshed: 2 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03749135.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing