LOU064 (blinded) for Chronic Spontaneous Urticaria

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novartis Investigative Site, Langenau, Germany
Chronic Spontaneous Urticaria+2 More
LOU064 (blinded) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1- Antihistamines

See full description

Eligible Conditions

  • Chronic Spontaneous Urticaria

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Chronic Spontaneous Urticaria

Study Objectives

This trial is evaluating whether LOU064 (blinded) will improve 2 primary outcomes and 10 secondary outcomes in patients with Chronic Spontaneous Urticaria. Measurement will happen over the course of 2 weeks.

12 weeks
Absolute change in ISS7 an absolute change in HSS7 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)
Achievement of DLQI = 0-1
Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint)
Change from baseline in UAS7 (only in scenario 2)
Complete absence of hives and itch (UAS7 = 0)
Disease activity control (UAS7 ≤ 6)
Number of weeks without angiodema (AAS7 = 0)
Reduction in weekly ISS score (only in scenario 1)
Reduction of weekly HSS score (only in scenario 1)
Sustained disease activity control (UAS7 ≤ 6)
2 weeks
Early onset of disease activity control
56 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of remibrutinib]

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Chronic Spontaneous Urticaria

Trial Design

2 Treatment Groups

Arm 1: LOU064 (blinded)
1 of 2
Arm 2: LOU064 placebo (blinded)
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 450 total participants across 2 different treatment groups

This trial involves 2 different treatments. LOU064 (blinded) is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Arm 1: LOU064 (blinded)LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomised in 2:1 ratio (active vs placebo)
Arm 2: LOU064 placebo (blinded)LOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomised in 2:1 ratio (active vs placebo)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 56 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 56 weeks for reporting.

Closest Location

Novartis Investigative Site - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Signed informed consent must be obtained prior to participation in the study.
Male and female adult participants ≥18 years of age at the time of screening.
CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation).
The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines during this time period
UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥ 6 during the 7 days prior to randomization (Day 1)
Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants medical history).
Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1).

Patient Q&A Section

What is chronic spontaneous urticaria?

"The symptom of chronic spontaneous urticaria may affect all ages of a patient's life. Therefore, treatment is important to prevent the symptom from becoming severe. This symptom is very difficult to treated and this justifies the need of new drugs." - Anonymous Online Contributor

Unverified Answer

How many people get chronic spontaneous urticaria a year in the United States?

"Because CSUs affect millions of U.S. adults, the cost of CSU to society is high. The American National Institutes of Health considers CSU to be one of the nation's most neglected and underserved conditions. These facts, along with the fact that CSU affects many young patients, cause us to encourage individuals with CSU to seek out information and treatments that can improve their quality of life." - Anonymous Online Contributor

Unverified Answer

What are the signs of chronic spontaneous urticaria?

"Most patients with chronic spondyloarthritis present with urticarial skin lesions. However, none of the patients with chronic spontaneous urticaria have skin lesions of a specific pattern typically seen in chronic spondyloarthritis. The diagnosis of chronic spontaneous urticaria is usually made as an incidental finding and many patients do not want to take any medication in view of the side effects. In certain situations treatment with antihistamine medications should be considered." - Anonymous Online Contributor

Unverified Answer

What are common treatments for chronic spontaneous urticaria?

"As for many other medically unexplained conditions, treatments focus on alleviating the physical symptoms of the disease, and symptom management is paramount. As it is difficult to distinguish the underlying physiological mechanism, the best course of treatment still remains elusive." - Anonymous Online Contributor

Unverified Answer

Can chronic spontaneous urticaria be cured?

"S. lichenoides can be an effective treatment for chronic spontaneous urticaria in women. The mechanism could be related to the antiestrogen effects of S. lichenoides or its antiinflammatory properties. S. lichenoides could be a treatment for chronic spontaneous urticaria." - Anonymous Online Contributor

Unverified Answer

What causes chronic spontaneous urticaria?

"When diagnosing idiopathic CSU, it might be beneficial to include a question about the history of the disease. The use of a PDEI, cetirizine, might be beneficial, but further larger studies are needed." - Anonymous Online Contributor

Unverified Answer

How serious can chronic spontaneous urticaria be?

"Although CSU has been classified as a more severe form of urticaria, our data suggest that CSU is associated with significant disease burden even in patients with early disease severity who are treated with appropriate medication." - Anonymous Online Contributor

Unverified Answer

What is lou064 (blinded)?

"The present retrospective study shows that the patients in group A reported a statistically significant and consistent reduction in pruritus when compared with placebo in both the whole population of patients and patients with CSU, with an estimated response rate at week 18 of 52% and 43%, respectively. It is therefore plausible that in a prospective, blinded trial a larger percentage of patients could benefit from LOU064." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving lou064 (blinded)?

"We determined that there have been very few other trials evaluating the safety and efficacy of the lupus medication, lopatuzumab ((trade name) Lucentis). Most of these trials were examining the effect on arthritis. Other clinical trials have not been blinded or well-designed." - Anonymous Online Contributor

Unverified Answer

Does lou064 (blinded) improve quality of life for those with chronic spontaneous urticaria?

"A single outpatient visit of up to 30 minutes using lou064 in combination with other treatments has a significant effect on quality of life for those patients with chronic spontaneous urticaria. In a recent study, findings are consistent with evidence that lou064 increases QoL and reduces daily itch severity in patients with chronic itch." - Anonymous Online Contributor

Unverified Answer

Is lou064 (blinded) safe for people?

"Subjects receiving lou064 had similar rates of adverse events to placebo. While it is likely that lou064 is safe when used as a treatment option for CSU, further studies to examine safety in a larger population is warranted." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of lou064 (blinded)?

"Most patients taking lou064 experienced [mild to moderate (2/6), moderate (6/6), or severe (16/18)] [increased/decreased (1/6), increased (5/6), decreased (2/6) symptoms]. Only 1/11 showed serious allergic reaction. Based on the data gathered from the clinical trials that lou064 passed, lou064 may be an effective treatment for CSU." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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