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Bruton's Tyrosine Kinase (BTK) Inhibitor

LOU064 for Chronic Urticaria

Q: Is the eligibility for this medical study restricted to individuals under 25 years of age?

This clinical trial permits minors aged 12 to 17 to participate. There are 6 studies catering toward younger patients and 30 for elderly citizens over the age of 65.

Q: What potential risks have been linked to the use of LOU064 (blinded) in arm one?

Arm 1: LOU064 (blinded) has been given a safety rating of 3 due to the multiple rounds of data collection that support efficacy and provide evidence for its security.

Q: What is the current intake capacity for participants of this experiment?

Affirmative. According to clinicaltrials.gov, the medical trial posted on July 11th 2023 is still making enrolments. It requires 84 people from 8 different institutions for participation in this study.

Q: How many centers are involved in the oversight of this clinical trial?

Currently, 8 sites are administering this trial. These centres are located in Singapore, Adana and Ankara alongside 5 other cities. To reduce travel burden for participants involved in the study, we recommend selecting a site that is nearby your home address.

Q: Are additional participants being sought to partake in this research?

Clinicaltrials.gov reports that the research study, which was initially published on July 11th 2023, is in search of participants. The page has been updated as recently as October 30th 2023.

Q: Is there an opportunity for me to partake in this medical experiment?

This clinical trial is searching for 84 adolescents aged 12 to 17, suffering from chronic urticaria. Candidates must be male or female, and present with at least 6 weeks of itching and hives despite the use of H1-AH therapy in accordance to local regulations. Furthermore, they should have a UAS7 score ≥16; plus ISS7 and HSS7 scores both greater than or equal to 6 during the week prior to randomization (Day 1). A history of hives within 3 months before enrollment can also suffice as proof for inclusion criteria.

Q: What are the desired outcomes of this experiment?

This trial's central objective, which will be measured from Baseline to Week 12, is the alteration of UAS7. The secondary goals entail determining Tmax for remibrutinib, achieving a UAS7 score of less than 6 (yes/no), and calculating weeks without angioedema based on AAS7 responses. Urticaria Activity Score quantifies hives severity along with itch intensity while Angioedema Activity Score gauges frequency and intensity of episodes over seven days.

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as: The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines

Male and female adolescent participants aged ≥ 12 to < 18 years of age at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial tests a drug to help adolescents with urticaria not controlled by antihistamines. It will measure safety, effectiveness and how the drug works over 3 years.

Who is the study for?

Adolescents aged 12 to under 18 with chronic spontaneous urticaria (hives) not well-controlled by antihistamines can join. They must have had hives for at least six months and show certain scores on itch and hive severity scales. Those with liver disease, other skin conditions causing itching, or a history of severe allergic reactions to similar drugs cannot participate.Check my eligibility

What is being tested?

The trial is testing the effectiveness of LOU064 (remibrutinib), a medication against placebo in adolescents who haven't responded well to antihistamines for their chronic hives. It includes an initial 24-week double-blind phase followed by up to three years where all participants may receive remibrutinib.See study design

What are the potential side effects?

Possible side effects are not explicitly listed but typically include reactions related to the immune system, digestive issues, and potential risks associated with long-term use which will be monitored over the course of treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have chronic hives and itching for over 6 weeks despite taking allergy medication.

Select...

I am between 12 and 17 years old.

Select...

I have had chronic spontaneous urticaria for 6 months or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years 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 HSS7

Change from baseline in UAS7

Change fron baseline in ISS7

Secondary outcome measures

AUClast of remibrutinib

Absolute change from baseline in CDLQI score

Absolute change from baseline in HSS7

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1: LOU064 (blinded)Experimental Treatment1 Intervention

LOU064 (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for up to 6 cycles of 24 weeks.

Group II: Arm 2: LOU064 placebo (blinded)Placebo Group1 Intervention

LOU064 placebo (blinded) taken orally b.i.d. for 24 weeks (randomized in a 2:1 ratio arm 1: arm 2)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LOU064 (blinded)

2021

Completed Phase 3

~930

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,225 Total Patients Enrolled

27 Trials studying Chronic Urticaria

9,040 Patients Enrolled for Chronic Urticaria

Frequently Asked Questions

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

Is the eligibility for this medical study restricted to individuals under 25 years of age?

"This clinical trial permits minors aged 12 to 17 to participate. There are 6 studies catering toward younger patients and 30 for elderly citizens over the age of 65."

Answered by AI

What potential risks have been linked to the use of LOU064 (blinded) in arm one?

"Arm 1: LOU064 (blinded) has been given a safety rating of 3 due to the multiple rounds of data collection that support efficacy and provide evidence for its security."

Answered by AI

What is the current intake capacity for participants of this experiment?

"Affirmative. According to clinicaltrials.gov, the medical trial posted on July 11th 2023 is still making enrolments. It requires 84 people from 8 different institutions for participation in this study."

Answered by AI

How many centers are involved in the oversight of this clinical trial?

"Currently, 8 sites are administering this trial. These centres are located in Singapore, Adana and Ankara alongside 5 other cities. To reduce travel burden for participants involved in the study, we recommend selecting a site that is nearby your home address."

Answered by AI

Are additional participants being sought to partake in this research?

"Clinicaltrials.gov reports that the research study, which was initially published on July 11th 2023, is in search of participants. The page has been updated as recently as October 30th 2023."

Answered by AI

Is there an opportunity for me to partake in this medical experiment?

"This clinical trial is searching for 84 adolescents aged 12 to 17, suffering from chronic urticaria. Candidates must be male or female, and present with at least 6 weeks of itching and hives despite the use of H1-AH therapy in accordance to local regulations. Furthermore, they should have a UAS7 score ≥16; plus ISS7 and HSS7 scores both greater than or equal to 6 during the week prior to randomization (Day 1). A history of hives within 3 months before enrollment can also suffice as proof for inclusion criteria."

Answered by AI

What are the desired outcomes of this experiment?

"This trial's central objective, which will be measured from Baseline to Week 12, is the alteration of UAS7. The secondary goals entail determining Tmax for remibrutinib, achieving a UAS7 score of less than 6 (yes/no), and calculating weeks without angioedema based on AAS7 responses. Urticaria Activity Score quantifies hives severity along with itch intensity while Angioedema Activity Score gauges frequency and intensity of episodes over seven days."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up

2023. "24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05677451.

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