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Befejeződött3. fázis

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)

A legfontosabb adatok

Ki végzi
Sanofi
Hol
Baltimore, Charleston, Charlotte, Cincinnati, Dallas, Los Angeles, Owensboro, Pittsburgh, Rochester, San Antonio, Sarasota, Savannah, St Louis, Sweetwater, Tampa és Tulsa (Egyesült Államok)Mind a 16 helyszín megnézéseMég 10 másik országban, 82 helyszínen
Azonosító
Állapot
Befejeződött
Fázis
3. fázis
Résztvevők
397 fő vett részt
Kezdés
2019. dec. 11.
Befejezés
2024. okt. 25.
A vizsgálat típusa
Beavatkozással járó, 6 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • Dupilumab SAR231893
  • Placebo
  • non sedating H1-antihistamine
A regiszteradat frissítve
2025. augusztus 20.

Ki vehet részt

Életkor
6 év – 80 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 22 feltétel megnézéseKevesebb

Ki vehet részt

  • Study A and C: Participant were ≥6 years to 80 years of age at the time of signing the informed consent
  • Study B: Participant were ≥12 years (or the minimum legal age for adolescents in the country of the investigational site) to 80 years of age at the time of signing the informed consent
  • Participants who had a diagnosis of CSU refractory to H1 antihistamines (H1-AH) at the time of randomization defined by
  • Diagnosis of CSU>6 months prior to screening visit
  • Presence of itch and hives for >6 consecutive weeks at any time prior to screening visit despite the use of H1-AH during that time period
  • Used a study defined H1-antihistamine for CSU treatment
  • During the 7 days before randomization:; UAS7≥16 ISS7≥ 8
  • Study A and C: omalizumab naïve, Study B; intolerant or incomplete responder to omalizumab
  • Participants were willing and able to complete a daily symptom e-Diary for the duration of the study

Ki nem vehet részt

  • Severe concomitant illness(es) that, in the investigator's judgment, would have adversely affected the participant's participation in the study
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and during the screening period
  • Participation in prior dupilumab clinical study, or have been treated with commercially available dupilumab; The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial
  • Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated
  • Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
  • Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
  • History of systemic hypersensitivity or anaphylaxis to omalizumab or any biologic therapy, including any excipients
  • Weight was less than 30 kg in adults and adolescents and 15 kg in children aged 6 to<12years
  • Participants were excluded from any of the studies if any of the following criteria apply:
  • Clearly defined underlying etiology for chronic urticarias other than CSU
  • Presented of skin morbidities other than CSU that may interfere with the assessment of the study outcomes
  • Active atopic dermatitis
  • Known or suspected immunodeficiency

Helyszínek itt: Egyesült Államok

Még 10 másik országban, 82 helyszínen

  • Johns Hopkins University (Asthma and Allergy Center) Site Number : 8400016Baltimore, Egyesült Államok
  • National Allergy and ENT Site Number : 8400011Charleston, Egyesült Államok
  • Immunocarolina LLC Site Number : 8400010Charlotte, Egyesült Államok
  • Bernstein Clinical Research Center Site Number : 8400014Cincinnati, Egyesült Államok
  • Pharmaceutical Research & Consulting, Inc. Site Number : 8400003Dallas, Egyesült Államok
  • California Allergy and Asthma Medical Group, Inc. Site Number : 8400019Los Angeles, Egyesült Államok
  • Allergy & Asthma Specialists, PSC Site Number : 8400020Owensboro, Egyesült Államok
  • Allergy and Clinical Immunology Associates Site Number : 8400024Pittsburgh, Egyesült Államok
  • UR Dermatology at College Town Site Number : 8400008Rochester, Egyesült Államok
  • STAAMP Research, LLC Site Number : 8400007San Antonio, Egyesült Államok
  • Sarasota, FloridaHospital not named in the registry
  • Aeroallergy Research Laboratories of Savannah, INC Site Number : 8400018Savannah, Egyesült Államok
  • The Clinical Research Center, LLC Site Number : 8400009St Louis, Egyesült Államok
  • Lenus Research & Medical Group Site Number : 8400001Sweetwater, Egyesült Államok
  • University of South Florida Site Number : 8400006Tampa, Egyesült Államok
  • Vital Prospects Clinical Research Institute, P.C. Site Number : 8400015Tulsa, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

Primary Objective:

A teljes eredeti leírásKevesebb

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

A vizsgálat 6 csoportja

  • Study A DupilumabA vizsgált kezelés

    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.

    Kezelés: Dupilumab SAR231893 és non sedating H1-antihistamine

  • Study A PlaceboPlacebo, összehasonlításként

    Participants who were omalizumab naïve received placebo matched to dupilumab as subcutaneous (SC) injection including loading dose from Day 1 up to 24 weeks.

    Kezelés: Placebo és non sedating H1-antihistamine

  • Study B DupilumabA vizsgált kezelés

    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.

    Kezelés: Dupilumab SAR231893 és non sedating H1-antihistamine

  • Study B PlaceboPlacebo, összehasonlításként

    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.

    Kezelés: Placebo és non sedating H1-antihistamine

  • Study C DupilumabA vizsgált kezelés

    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.

    Kezelés: Dupilumab SAR231893 és non sedating H1-antihistamine

  • Study C PlaceboPlacebo, összehasonlításként

    Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.

    Kezelés: Placebo és non sedating H1-antihistamine

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab
Publikációk
A regiszteradat frissítve
2025. augusztus 20.