Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT04833855
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tezepelumab Dose 1 — BIOLOGICAL
    Subcutaneous injection.
  • Tezepelumab Dose 2 — BIOLOGICAL
    Subcutaneous injection.
  • Omalizumab — BIOLOGICAL
    Subcutaneous injection.
  • Placebo — BIOLOGICAL
    Subcutaneous injection.

Study Details

The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).

Key Dates

Start date
Apr 15, 2021
Status verified
Apr 2025
Primary completion
Dec 20, 2022
Completion
Apr 13, 2023

Study Design

Enrollment
183 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1: Omalizumab
    Participants naive to anti-IgE therapies will receive omalizumab.
  • Placebo Comparator: Group 2: Placebo
    Participants naive to anti-IgE therapies will receive a placebo.
  • Experimental: Group 3: Tezepelumab Dose 1
    Participants naive to anti-IgE therapies will receive tezepelumab.
  • Experimental: Group 4: Tezepelumab Dose 2
    Participants naive to anti-IgE therapies will receive tezepelumab.
  • Placebo Comparator: Group 5: Placebo
    Participants previously treated with anti-IgE therapies will receive a placebo.
  • Experimental: Group 6: Tezepelumab Dose 1
    Participants previously treated with anti-IgE therapies will receive tezepelumab.
  • Experimental: Group 7: Tezepelumab Dose 2
    Participants previously treated with anti-IgE therapies will receive tezepelumab.

Primary Outcome Measure

Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Clinical Research Center of AlabamaBirminghamAlabama35209-
First OC DermatologyFountain ValleyCalifornia92708-
Avance Clinical TrialsLaguna NiguelCalifornia92677-
Dermatology Research AssociatesLos AngelesCalifornia90045-
Jonathan Corren MD IncLos AngelesCalifornia90025-
Clinical Science InstituteSanta MonicaCalifornia90404-
Asthma and Allergy Associates PCColorado SpringsColorado80907-
The Community Research of South FloridaMiami LakesFlorida33016-
Advanced Medical Research PCSandy SpringsGeorgia30328-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-
Epiphany Dermatology of Kansas, LLCOverland ParkKansas66210-
Bluegrass Allergy CareLexingtonKentucky40509-
Family Allergy and Asthma Research InstituteLouisvilleKentucky40215-
Johns Hopkins Asthma and Allergy CenterBaltimoreMaryland21224-
David Fivenson MD Professional Liability CompanyAnn ArborMichigan48103-
Clarkston Skin ResearchClarkstonMichigan48346-
Henry Ford Medical Center - New Center OneDetroitMichigan48202-
Washington University School of MedicineSt LouisMissouri63110-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Bernstein Clinical Research Center LLCCincinnatiOhio45236-
Aventiv Research IncDublinOhio43016-
Clinical Partners LLCJohnstonRhode Island02919-
The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical ResearchKnoxvilleTennessee37909-
Suzanne Bruce and AssociatesHoustonTexas77056-
Cutis Wellness Dermatology and Dermatopathology, PLLCLaredoTexas78041-

Find similar trials in Birmingham, AL

By research site
Clinical Research Center of Alabama· Birmingham, ALFirst OC Dermatology· Fountain Valley, CAAvance Clinical Trials· Laguna Niguel, CADermatology Research Associates· Los Angeles, CAJonathan Corren MD Inc· Los Angeles, CAClinical Science Institute· Santa Monica, CA

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