← Back to Search

Monoclonal Antibodies

Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria (INCEPTION Trial)

Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 pre-dose, weeks 2, 4, 8, 12, 16, 24, and 32

Summary

This trial is testing tezepelumab, a medication that helps reduce symptoms of hives. It targets patients with urticaria, aiming to improve their condition by blocking a protein that causes inflammation and allergic reactions. The goal is to see if it can lower their symptoms effectively.

Eligible Conditions
  • Chronic Urticaria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 pre-dose, weeks 2, 4, 8, 12, 16, 24, and 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 pre-dose, weeks 2, 4, 8, 12, 16, 24, and 32 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 16
Secondary study objectives
Change From Baseline in HSS Over 7 Days (HSS7) at Week 16
Change From Baseline in ISS Over 7 Days (ISS7) at Week 16
Change From Baseline in SQS7: Sum of Average Daily Q1 - Q3 at Week 16
+21 more

Side effects data

From 2023 Phase 2 trial • 183 Patients • NCT04833855
10%
Pyrexia
6%
COVID-19
3%
Intentional self-injury
3%
Nasopharyngitis
3%
Headache
3%
Eczema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Omalizumab 300 mg SC Q4W
Tezepelumab 210 mg SC Q4W
Tezepelumab 420 mg SC Q2W

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group 7: Tezepelumab Dose 2Experimental Treatment1 Intervention
Participants previously treated with anti-IgE therapies will receive tezepelumab.
Group II: Group 6: Tezepelumab Dose 1Experimental Treatment1 Intervention
Participants previously treated with anti-IgE therapies will receive tezepelumab.
Group III: Group 4: Tezepelumab Dose 2Experimental Treatment1 Intervention
Participants naive to anti-IgE therapies will receive tezepelumab.
Group IV: Group 3: Tezepelumab Dose 1Experimental Treatment1 Intervention
Participants naive to anti-IgE therapies will receive tezepelumab.
Group V: Group 1: OmalizumabActive Control1 Intervention
Participants naive to anti-IgE therapies will receive omalizumab.
Group VI: Group 5: PlaceboPlacebo Group1 Intervention
Participants previously treated with anti-IgE therapies will receive a placebo.
Group VII: Group 2: PlaceboPlacebo Group1 Intervention
Participants naive to anti-IgE therapies will receive a placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab Dose 1
2021
Completed Phase 2
~190
Tezepelumab Dose 2
2021
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,442 Previous Clinical Trials
1,397,561 Total Patients Enrolled
MDStudy DirectorAmgen
980 Previous Clinical Trials
941,317 Total Patients Enrolled
~39 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top