Trial · NCT04180488

Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)

NCT04180488, Phase 3, Completed, Sanofi; results first posted 2025-08-20

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID). Trials, record NCT04180488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04180488

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
NCT number: NCT04180488
Status: Completed
Phases: Phase 3
Enrollment: 397 participants, actual
Lead sponsor: Sanofi
Conditions: Chronic Spontaneous Urticaria
Interventions: Dupilumab SAR231893, Placebo, non sedating H1-antihistamine
First posted: 2019-11-27
Last updated: 2025-08-20
Other registries' IDs: eudract:2019-003775-19
Results first posted: 2025-08-20

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Weekly Itch Severity Score at Week 24	Baseline (Day 1) and Week 24	ISS was recorded in e-diary. The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. Least squares (LS) mean is presented. Baseline was defined as the sum of daily scores obtained for 7 days prior to randomization.
Secondary	Change From Baseline in Weekly Urticaria Activity Score at Week 24	Baseline (Day 1) and Week 24	UAS is a validated composite patient-reported outcome (PRO) measure for assessing chronic spontaneous urticaria (CSU) activity. The once daily UAS is the sum of the daily hives severity score (HSS) and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. LS mean is presented. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Secondary	Change From Baseline in Weekly Hives Severity Score at Week 24	Baseline (Day 1) and Week 24	Daily HSS was recorded in e-diary. The HSS7 score is the sum of daily HSS ranging from 0 (none) to 3 (more than 50 hives) recorded by a participant at the same time of each day over 7 days with an overall scale of 0 (no hives) to 21 (severe hives). Higher scores indicate greater intensity of hives. LS mean is presented. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Secondary	Percentage of Responders for Weekly Itch Severity Score Minimally Important Difference (MID) at Week 24	Week 24	The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. An ISS7 MID response was defined as \>=5 points decrease from baseline after study intervention.
Secondary	Percentage of Participants With Weekly Urticaria Activity Score <=6 at Week 24	Week 24	UAS is a validated composite PRO measure for assessing CSU activity. The once daily UAS is the sum of the daily HSS and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. In evaluating urticaria control using UAS7, an UAS7 score of \<=6 indicated a well-controlled urticaria.
Secondary	Percentage of Participants With Weekly Urticaria Activity Score =0 at Week 24	Week 24	UAS is a validated composite PRO measure for assessing CSU activity. The once daily UAS is the sum of the daily HSS and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. In evaluating urticaria control using UAS7, an UAS7 score of 0 indicated an absence of both itch and hives and a complete resolution of CSU symptoms.
Secondary	Change From Baseline in Urticaria Control Test (UCT) at Week 24	Baseline (Day 1) and Week 24	The UCT assessed urticaria control based on 4 items (severity of pruritus and wheals urticaria symptoms; frequency of treatment being not sufficient; quality-of-life \[QoL\] impairment; overall urticarial control). Each item was rated on a 5-point Likert-type scale from 0 (no control) to 4 (maximum control). The overall UCT score was the sum of all 4 individual item scores with a range of 0 (no disease control) to 16 (complete disease control). Higher scores indicated greater disease control. LS mean is presented. Baseline was defined as the last available value up to randomization date and prior to the first dose of study intervention.
Secondary	Change From Baseline in Weekly Itch Severity Score at Week 12	Baseline (Day 1) and Week 12	ISS was recorded in e-diary. The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. LS mean is presented. Baseline was defined as the sum of daily scores obtained for 7 days prior to randomization.
Secondary	Change From Baseline in Weekly Urticaria Activity Score at Week 12	Baseline (Day 1) and Week 12	UAS is a validated composite PRO measure for assessing CSU activity. The once daily UAS is the sum of the daily HSS and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. LS mean is presented. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Secondary	Percentage of Participants With Weekly Urticaria Activity Score <=6 and =0 at Week 12	Week 12	UAS is a validated composite PRO measure for assessing CSU activity. The once daily UAS is the sum of the daily HSS and daily ISS recorded in e-diary. Daily HSS assesses number of wheals and range from 0 (none) to 3 (more than 50 hives) whereas daily ISS assesses itch intensity and range from 0 (none) to 3 (intense). The daily UAS scores range from 0 to 6 point/day. Once daily UAS scores are summed over 7-day period to create the UAS7 with an overall scale of 0 (no urticaria) to 42 (severe urticaria). Higher scores indicate greater severity of urticaria symptoms. In evaluating urticaria control using UAS7, an UAS7 score of \<=6 indicated a well-controlled urticaria and an UAS7 score of 0 indicated an absence of both itch and hives and a complete resolution of CSU symptoms.

1 to 10 of 25Source ClinicalTrials.gov

See all 25 registered outcomes

Outcomes25

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Weekly Itch Severity Score at Week 24	Baseline (Day 1) and Week 24	The intent-to-treat (ITT) population included all randomized participants analyzed according to the intervention group allocated by randomization.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weekly Urticaria Activity Score at Week 24	Baseline (Day 1) and Week 24	The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weekly Hives Severity Score at Week 24	Baseline (Day 1) and Week 24	The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Responders for Weekly Itch Severity Score Minimally Important Difference (MID) at Week 24	Week 24	The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Weekly Urticaria Activity Score <=6 at Week 24	Week 24	The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Weekly Urticaria Activity Score =0 at Week 24	Week 24	The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Urticaria Control Test (UCT) at Week 24	Baseline (Day 1) and Week 24	The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weekly Itch Severity Score at Week 12	Baseline (Day 1) and Week 12	The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weekly Urticaria Activity Score at Week 12	Baseline (Day 1) and Week 12	The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Weekly Urticaria Activity Score <=6 and =0 at Week 12	Week 12	The ITT population included all randomized participants analyzed according to the intervention group allocated by randomization.	percentage of participants	NUMBER

1 to 10 of 25Source ClinicalTrials.gov

See all 25 outcomes

Results by group213

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Weekly Itch Severity Score at Week 24	Study A: Placebo	-6.01	Standard Error 0.94	score on a scale
Change From Baseline in Weekly Itch Severity Score at Week 24	Study A: Dupilumab	-10.24	Standard Error 0.91	score on a scale
Change From Baseline in Weekly Itch Severity Score at Week 24	Study B: Placebo	-4.81	Standard Error 1.08	score on a scale
Change From Baseline in Weekly Itch Severity Score at Week 24	Study B: Dupilumab	-7.68	Standard Error 1.10	score on a scale
Change From Baseline in Weekly Itch Severity Score at Week 24	Study C: Placebo	-6.10	Standard Error 1.40	score on a scale
Change From Baseline in Weekly Itch Severity Score at Week 24	Study C: Dupilumab	-8.64	Standard Error 1.41	score on a scale
Change From Baseline in Weekly Urticaria Activity Score at Week 24	Study A: Placebo	-12.00	Standard Error 1.81	score on a scale
Change From Baseline in Weekly Urticaria Activity Score at Week 24	Study A: Dupilumab	-20.53	Standard Error 1.76	score on a scale
Change From Baseline in Weekly Urticaria Activity Score at Week 24	Study B: Placebo	-8.54	Standard Error 2.14	score on a scale
Change From Baseline in Weekly Urticaria Activity Score at Week 24	Study B: Dupilumab	-14.37	Standard Error 2.16	score on a scale

1 to 10 of 213Source ClinicalTrials.gov

See all 213 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Study A: Placebo	68
Overall Study	STARTED	Study A: Dupilumab	70
Overall Study	STARTED	Study B: Placebo	54
Overall Study	STARTED	Study B: Dupilumab	54
Overall Study	STARTED	Study C: Placebo	77
Overall Study	STARTED	Study C: Dupilumab	74
Overall Study	COMPLETED	Study A: Placebo	55
Overall Study	COMPLETED	Study A: Dupilumab	63
Overall Study	COMPLETED	Study B: Placebo	47
Overall Study	COMPLETED	Study B: Dupilumab	49

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events168

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Covid-19	Infections and infestations	Study A: Placebo	2	68	2
other	Covid-19	Infections and infestations	Study A: Dupilumab	1	70	1
other	Covid-19	Infections and infestations	Study B: Placebo	4	54	4
other	Covid-19	Infections and infestations	Study B: Dupilumab	5	54	5
other	Covid-19	Infections and infestations	Study C: Placebo	4	77	4
other	Covid-19	Infections and infestations	Study C: Dupilumab	6	74	6
other	Nasopharyngitis	Infections and infestations	Study A: Placebo	3	68	3
other	Nasopharyngitis	Infections and infestations	Study A: Dupilumab	1	70	1
other	Nasopharyngitis	Infections and infestations	Study B: Placebo	4	54	5
other	Nasopharyngitis	Infections and infestations	Study B: Dupilumab	1	54	1

1 to 10 of 168Source ClinicalTrials.gov

See all 168 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Study A: Placebo	1	68
Total, all-cause mortality	Study A: Dupilumab	0	70
Total, all-cause mortality	Study B: Placebo	0	54
Total, all-cause mortality	Study B: Dupilumab	0	54
Total, all-cause mortality	Study C: Placebo	0	77
Total, all-cause mortality	Study C: Dupilumab	0	74
Total, other adverse events	Study A: Placebo	19	68
Total, other adverse events	Study A: Dupilumab	12	70
Total, other adverse events	Study B: Placebo	15	54
Total, other adverse events	Study B: Dupilumab	17	54

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
39066978	DERIVED	PubMed
41272364	DERIVED	PubMed
41326897	DERIVED	PubMed
41706458	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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