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Bruton's Tyrosine Kinase (BTK) Inhibitor
Rilzabrutinib for Hives (RILECSU Trial)
Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The presence of itch and hives for ≥6 consecutive weeks at any time prior to screening visit (Visit 1) despite the use of H1-AH during this time period
Participants who have a diagnosis of CSU refractory to H1-AH at the time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until week 52
Awards & highlights
RILECSU Trial Summary
This trial is testing the safety and effectiveness of rilzabrutinib compared to placebo for decreasing the frequency and severity of itch and urticaria in people with CSU. The trial has a double-blind phase, where some people will receive rilzabrutinib and some will receive placebo, and an open-label extension phase, where everyone will receive rilzabrutinib.
Who is the study for?
Adults aged 18+ with Chronic Spontaneous Urticaria (CSU) who still have itch and hives despite using H1 Antihistamines for over 6 weeks. They must not have other skin conditions or severe illnesses that could affect the study, no recent serious infections, and cannot be on certain medications like BTK inhibitors or investigational drugs.Check my eligibility
What is being tested?
The trial is testing three oral doses of a drug called rilzabrutinib against a placebo to see if it can reduce itchiness and hives in CSU patients. It's a double-blind study initially lasting 12 weeks, followed by an optional open-label phase where all participants receive rilzabrutinib for up to 40 additional weeks.See study design
What are the potential side effects?
Possible side effects of rilzabrutinib may include increased risk of bleeding, potential immune system impacts leading to more frequent or prolonged infections, and possibly other reactions that are common with new medications being tested.
RILECSU Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had itch and hives for 6 weeks or more, even while using antihistamines.
Select...
My chronic hives do not improve with standard allergy medications.
Select...
I have never taken omalizumab or it did not work well for me.
RILECSU Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until week 52
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 weekly urticaria activity score (UAS7) at Week 12 (except US and US reference countries)
For US and US reference countries only: change from baseline in weekly itch severity score (ISS7) at Week 12
Secondary outcome measures
Change from baseline in ISS7 at Week 12 (except US and US reference countries)
Change from baseline in UAS7 at Week 4
Change from baseline in weekly hives severity score (HSS7) at Week 12
+5 moreRILECSU Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Rilzabrutinib dose CExperimental Treatment1 Intervention
dose C
Group II: Rilzabrutinib dose BExperimental Treatment1 Intervention
dose B
Group III: Rilzabrutinib dose AExperimental Treatment1 Intervention
dose A
Group IV: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rilzabrutinib
2021
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,165 Previous Clinical Trials
3,515,141 Total Patients Enrolled
3 Trials studying Chronic Urticaria
493 Patients Enrolled for Chronic Urticaria
Clinical Sciences & OperationsStudy DirectorSanofi
863 Previous Clinical Trials
2,020,007 Total Patients Enrolled
1 Trials studying Chronic Urticaria
397 Patients Enrolled for Chronic Urticaria
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have skin conditions that could affect the study's results.I am using or can switch to a study-approved allergy medication for my chronic hives.I have had itch and hives for 6 weeks or more, even while using antihistamines.You have tested positive for HIV.In the 7 days before being chosen for the study, you had a skin condition score of 16 or higher and an itch score of 8 or higher.I have a condition that could cause me to bleed a lot.I have had cancer or still have it within the last 5 years.I haven't taken any experimental drugs or used experimental devices recently.I was diagnosed with chronic spontaneous urticaria more than 3 months ago.I haven't had serious infections needing IV treatment recently.I have tested positive for hepatitis B recently.I do not have any uncontrolled conditions like asthma or IBD that need steroids.You have abnormal results from blood tests or heart monitoring at the initial check-up.You have a weakened immune system or often get sick for a long time.My chronic hives are caused by a known physical trigger, not spontaneous.My chronic hives do not improve with standard allergy medications.I have not had any live vaccines, except for BCG, in the last 28 days or plan to during the trial.I have never taken omalizumab or it did not work well for me.I have active atopic dermatitis.I have previously used a BTK inhibitor.You have used a different experimental drug for chronic spontaneous urticaria in the past.I have tuberculosis.You have tested positive for hepatitis C in the past three months.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Rilzabrutinib dose B
- Group 3: Rilzabrutinib dose C
- Group 4: Rilzabrutinib dose A
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research require participants to be of legal age?
"This study is recruiting people aged 18-80. Out of the 42 total trials, 8 are for those under 18 and 34 are for seniors."
Answered by AI
Are we still enrolling individuals for this clinical trial?
"From what is available on clinicaltrials.gov, it seems that this trial is still looking for participants and is thus actively recruiting. The study was originally posted on 11/24/2021 with the latest edit taking place on 10/26/2022."
Answered by AI
In how many medical facilities is this clinical trial taking place?
"This trial is currently enrolling patients at six different investigational sites, three of which are in Quebec (Investigational Site Number :1240003, Investigational Site Number :1240005, and Investigational Site Number :1240008)."
Answered by AI
How many people are being enrolled in this medical study?
"That is correct, the online clinicaltrial information indicates that this study is presently looking for subjects. This trial was originally posted on November 24th 2021 and was last edited on October 26th 2022. The study requires 152 participants from 6 sites."
Answered by AI
Are there any documented risks associated with rilzabrutinib?
"At Power, we believe that rilzabrutinib is a level 2 medication in terms of safety. This is because while there is data supporting its safety, there are no trials testing its efficacy."
Answered by AI
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