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)

Conditions

• Chronic Spontaneous Urticaria

Eligibility Criteria

Sex

ALL

Age

6 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab SAR231893 — DRUG
  Pharmaceutical form:Injection solution Route of administration: Subcutaneous
• Placebo — DRUG
  Pharmaceutical form:Injection solution Route of administration: Subcutaneous
• non sedating H1-antihistamine — DRUG
  Pharmaceutical form:Tablet Route of administration: oral administration

Study Details

Primary Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders) Secondary Objectives: This study aimed to demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints This study aimed to demonstrate the efficacy of dupilumab on angioedema This study aimed to demonstrate the efficacy of dupilumab on urticaria control This study aimed to demonstrate improvement in health-related quality of life and overall disease status and severity This study aimed to evaluate the ability of dupilumab in reducing the proportion of participants who require treatment with oral corticosteroids (OCS) This study aimed to evaluate safety outcome measures This study aimed to evaluate immunogenicity of dupilumab

Key Dates

Start date

Dec 11, 2019

Status verified

Aug 2025

Primary completion

Aug 1, 2024

Completion

Oct 25, 2024

Study Design

Enrollment

397 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Study A Dupilumab
  Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 milligrams (mg) SC injection every 2 weeks (q2w) for adults and those adolescents who weighed \>=60 kilograms (kg) at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection every 4 weeks (q4w) for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
• Placebo Comparator: Study A Placebo
  Participants who were omalizumab naïve received placebo matched to dupilumab as subcutaneous (SC) injection including loading dose from Day 1 up to 24 weeks.
• Experimental: Study B Dupilumab
  Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.
• Placebo Comparator: Study B Placebo
  Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.
• Experimental: Study C Dupilumab
  Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
• Placebo Comparator: Study C Placebo
  Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.

Primary Outcome Measure

Change From Baseline in Weekly Itch Severity Score at Week 24 [ Time Frame: Baseline (Day 1) and Week 24 ]

Locations (16)

Find similar trials in Los Angeles, CA

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