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Monoclonal Antibodies

Benralizumab for Chronic Urticaria (ARROYO Trial)

Phase 2
Waitlist Available
Led By Sabine Altrichter, MD
Research Sponsored by AstraZeneca
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 pre-dose on weeks 4, 12 and 24
Awards & highlights

ARROYO Trial Summary

This trial will test whether the drug benralizumab can effectively treat people with chronic spontaneous urticaria who haven't been helped by antihistamines.

Eligible Conditions
  • Chronic Urticaria

ARROYO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose on weeks 4, 12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose on weeks 4, 12 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12
Secondary outcome measures
LS Mean Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Weeks 12 and 24
LS Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 12 and 24
LS Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) at Weeks 12 and 24
+9 more

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
16%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo

ARROYO Trial Design

5Treatment groups
Experimental Treatment
Group I: Placebo and BenralizumabExperimental Treatment1 Intervention
Placebo regimen A until Week 24, benralizumab Dose B regiment A until Week 36, and Dose B regimen B until Week 52 (n=40).
Group II: Benralizumab Arm 4Experimental Treatment1 Intervention
Benralizumab Dose B regimen A until Week 12, Dose B regimen A until Week 24, and Dose B regimen A during the extension period until Week 52 (n=30)
Group III: Benralizumab Arm 3Experimental Treatment1 Intervention
Benralizumab Dose B regimen A until Week 12, Dose B regimen A until Week 24, and Dose B regimen B during the extension period until Week 52 (n=30)
Group IV: Benralizumab Arm 2Experimental Treatment1 Intervention
Benralizumab Dose A regimen A until Week 12, Dose B regimen A until Week 24,and Dose B regimen A during the extension period until Week 52 (n=30)
Group V: Benralizumab Arm 1Experimental Treatment1 Intervention
Benralizumab Dose A regimen A until Week 12, Dose B regimen A until Week 24, and Dose B regimen B during the extension period until Week 52 (n=30)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 3
~10580

Find a Location

Who is running the clinical trial?

Iqvia Pty LtdIndustry Sponsor
107 Previous Clinical Trials
169,909 Total Patients Enrolled
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,700 Total Patients Enrolled
1 Trials studying Chronic Urticaria
38 Patients Enrolled for Chronic Urticaria
Sabine Altrichter, MDPrincipal InvestigatorCharite Universitaetsmedizin Berlin - Campus Charite Mitte

Frequently Asked Questions

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

Has Benralizumab been granted clearance by the FDA?

"Given the Phase 2 status of benralizumab, there is some evidence to suggest its safety but no data that can confidently attest to its efficacy. Therefore, our team at Power has assessed this medication's risk level as a '2'."

Answered by AI

Are there any available vacancies to join this trial?

"According to clinicaltrials.gov, this experiment is no longer accepting new patients at the moment—the listing was initially posted on October 27th 2020 and edited lastly on October 28th 2022. Nonetheless, there are 55 other tests that require participants right now."

Answered by AI

Does this clinical study accept volunteers aged 40 or more?

"This trial's enrolment requirements stipulate that individuals must be between 18 to 130 years old. Additionally, there are 12 research projects specifically catered towards minors and 52 trials which mainly cater to participants 65 or older."

Answered by AI

Is this an innovative scientific exploration?

"Benralizumab has been studied and developed for the past 7 years, beginning with a Phase 1 clinical trial sponsored by AstraZeneca in 2014. After initial success from this study of 20 participants, further trials were approved to move it into Phases 2 & 3. Currently there are 20 active studies being conducted across 352 cities and 42 countries worldwide."

Answered by AI

Could I qualify to get involved in this experiment?

"For this research, 155 adults aged 18 or above with urticaria are being recruited. The protocols for enrollment include the following conditions: Willingness to take a second-generation H1 antihistamine at approved dose until study completion; Signed and dated informed consent from patients prior to any tests or procedures; Diagnosis of chronic spontaneous urticaria (CSU) by physician for six months before screening visit; Pruritus and wheals over 6 weeks despite treatment with standard care, including up to 4 times regular doses of H1 antihistamines as monotherapy or in combination with leukotriene receptor antagonists (L"

Answered by AI

What other research endeavors have been conducted to scrutinize the efficacy of Benralizumab?

"At present, a total of 20 research studies are being conducted with Benralizumab. 10 of these trials have reached the third stage and Bethesda, Maryland constitutes the majority locale for this drug's testing. That said, there are 1489 locations globally that are executing clinical tests on Benralizumab."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
2020. "A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04612725.
~36 spots leftby Apr 2025
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