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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 baseline to week 32
Awards & highlights

INCEPTION Trial Summary

This trial will test whether the drug tezepelumab can improve the symptoms of hives (as measured by the UAS7 score).

Eligible Conditions
  • Chronic Urticaria

INCEPTION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Urticaria Activity Score over 7 days (UAS7)
Secondary outcome measures
Change from Baseline in Angioedema Activity Score over 7 Days (AAS7)
Change from Baseline in Angioedema Control Test (AECT) Score
Change from Baseline in Angioedema Quality of Life Questionnaire (AE-QoL) Score
+21 more

INCEPTION 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 2
2021
Completed Phase 2
~190
Tezepelumab Dose 1
2021
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,505 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,968 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals of all ages qualify for this research program?

"This trial is open to participants who fall between 18 and 80 years old-- anyone younger or older will be directed to the 16 other trials for minors or the 51 studies for seniors, respectively."

Answered by AI

Can new participants join this experiment at this time?

"The clinical trial in question, which was last updated on November 9th, 2022, is not currently recruiting patients. However, there are 63 other trials that are actively looking for participants."

Answered by AI

Are there any other cases in which Tezepelumab Dose 2 has been used before?

"8 out of the 26 ongoing clinical trials for Tezepelumab Dose 2 are in Phase 3. Although some of these tests are being conducted in Clarkston, Michigan - there are 593 active locations for this research worldwide."

Answered by AI

What have been the found effects of Tezepelumab Dose 2 in patients?

"Tezepelumab Dose 2 has only been evaluated in Phase 2 trials, so there is some data supporting its safety but none yet for efficacy. It received a score of 2 from our team."

Answered by AI

Does this test have specific eligibility requirements?

"This trial is looking for 183 participants that suffer from chronic urticaria and are aged between 18-80. In order to be eligible, potential patients must meet the following criteria: a diagnosis of Chronic spontaneous urticaria (CSU) for 6 months or longer at the time of screening, a score of 16 or higher on the Urticaria Activity Score over 7 days (UAS7) during the week prior to enrollment, a signed informed consent form, male or female gender, age 18-80 years old, evidence of itch and hives for 6 consecutive weeks at any point before screening visit 2, failure to respond"

Answered by AI

Is this clinical trial offered in more than one place?

"Patients can choose from a selection of 34 clinical trial sites, including the Icahn School of Medicine at Mount Sinai in New york, Johns Hopkins Asthma and Allergy Center in Baltimore, and Austin Institute for Clinical Research, Inc in Houston."

Answered by AI

What are the common medical conditions that Tezepelumab Dose 2 helps to alleviate?

"Tezepelumab Dose 2 can be used to manage perennial aeroallergen reactivity, histamine h1 antagonists, and non-sedating related symptoms that have not been improved by inhaled corticosteroids."

Answered by AI

What is the upper limit for patient recruitment in this clinical trial?

"Currently, this clinical trial is not looking for new patients. The study was first posted on April 15th, 2021 and updated November 9th, 2022. There are 37 other trials related to chronic urticaria recruiting participants and 26 studies involving Tezepelumab Dose 2 that are currently admitting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria
2021. "Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04833855.
~46 spots leftby Apr 2025
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