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Monoclonal Antibodies

Tezepelumab Dose 2 for Chronic 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
Awards & highlights

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
1,420 Previous Clinical Trials
1,382,767 Total Patients Enrolled
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,682 Total Patients Enrolled
~41 spots leftby Sep 2025
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