Branebrutinib for Eczema, Infantile

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Local Institution, Las Palmas De GC, Spain
Eczema, Infantile+2 More
Branebrutinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called branebrutinib can help treat atopic dermatitis.

See full description

Eligible Conditions

  • Eczema, Infantile

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Branebrutinib will improve 1 primary outcome and 23 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of At week 16.

At week 16
Mean change from baseline in percentage of affected body surface area (BSA) at week 16
Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at week 16
Mean percentage change from baseline in pruritus NRS score at week 16
Proportion of participants exhibiting a vIGA-AD score of 0 (cleared) or 1 (almost cleared) plus a ≥ 2-point reduction from baseline at week 16
Proportion of participants exhibiting a ≥ 4-point improvement from baseline in pruritus numerical rating scale (NRS) at week 16
Proportion of participants exhibiting a ≥ 50% Eczema Area and Severity Index (EASI-50) reduction from baseline EASI score at week 16
Up to 24 weeks
Incidence of all adverse events (AEs)
Severity of all AEs
Up to 29 weeks
Incidence of all serious adverse events (SAEs)
Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes from baseline values in clinical laboratory results: Coagulation panel
Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests
Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests
Incidence of clinically significant changes in ECG parameters: QRS interval
Incidence of clinically significant changes in ECG parameters: QT interval
Incidence of clinically significant changes in ECG parameters: QTcF interval
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Incidence of clinically significant changes in optical coherence tomography (OCT)
Incidence of clinically significant changes in pulmonary function tests (PFTs)
Incidence of clinically significant changes in vital signs: Blood pressure
Incidence of clinically significant changes in vital signs: Body temperature
Incidence of clinically significant changes in vital signs: Heart rate
Incidence of clinically significant changes in vital signs: Respiratory rate
Severity of all SAEs

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

5 Treatment Groups

Treatment BMS-986166 Dose 3
1 of 5
Treatment BMS-986166 Dose 1
1 of 5
Treatment BMS-986166 Dose 2
1 of 5
Treatment Branebrutinib
1 of 5
Placebo
1 of 5
Experimental Treatment
Non-Treatment Group

This trial requires 150 total participants across 5 different treatment groups

This trial involves 5 different treatments. Branebrutinib is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment BMS-986166 Dose 3
Drug
Treatment BMS-986166 Dose 1
Drug
Treatment BMS-986166 Dose 2
Drug
Treatment Branebrutinib
Drug
Placebo
Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986166
2021
Completed Phase 1
~350
Branebrutinib
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 29 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 29 weeks for reporting.

Closest Location

Local Institution - Verdun, Communauté-Urbaine-de-Montréal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of Hanifin's and Rajka's (E-HR) criteria at Screening
Disease duration of at least 24 months since diagnosis by any criteria
Documented history of inadequate control of AD by a stable regimen (≥ 4 weeks) of topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of randomization, or inappropriateness of therapy due to side effects or safety risks leading to prior discontinuation
Application of fixed doses of an additive-free, basic bland emollient twice-daily for ≥ 7 days before baseline visit and for the duration of the study

Patient Q&A Section

What are common treatments for dermatitis?

"Common treatments for dermatitis include topical steroids such as corticosteroids or tretinoin. The use of a shampoo or pomade has been shown to decrease symptoms. For more severe manifestations, systemic or oral corticosteroids may be prescribed. Another option is topical cyclosporine to prevent infection. For severe cases of dermatitis, topical tacrolimus or pimecrolimus has proven fruitful." - Anonymous Online Contributor

Unverified Answer

How many people get dermatitis a year in the United States?

"Almost 1 in 6 adults has atopic dermatitis on an at least-minimal basis in the United States annually. Dermatitis affects 8.4 million adults aged 3 years and older. Dermatitis is one of the most common reasons for physician visits." - Anonymous Online Contributor

Unverified Answer

What causes dermatitis?

"Contact to the skin is common. There is usually some type of chemical irritant involved, and some instances can be allergic (e.g., penicillin allergy). Most dermatoses are viral, with a rare bacterial or fungal origin. Skin diseases are also very prone to secondary skin infections, and, if untreated, can lead to malignant transformation." - Anonymous Online Contributor

Unverified Answer

What are the signs of dermatitis?

"Many of the signs and symptoms of dermatitis have been shown to be due to psychological factors, and only when other factors are excluded, will dermatitis be diagnosed in a patient. The lack of specific diagnostic tests does not justify indiscriminate dermatitis treatment, particularly for patients in whom the cause is psychiatric, psychosomatic, or other unknown." - Anonymous Online Contributor

Unverified Answer

Can dermatitis be cured?

"(1) It is difficult to justify the expense of dermatitis treatment in view of the minimal impact it has on most patients. (2) The value of this disease in treating, say, psoriasis is debatable, as the only people who are likely to benefit are patients with a very severe pruritic dermatitis. Even then, some people with severe psoriasis may benefit in other ways; in particular, they might benefit from reduction of inflammation by taking a calcineurin inhibitor. (3) It is important to know that psoriasis is not a curable disease, and that treatment should be tailored to the needs and expectations of the patient." - Anonymous Online Contributor

Unverified Answer

What is dermatitis?

"dermatitis is a skin disease, particularly of the chronic forms, that is caused by one's immune system over-responsively reacting to harmless substances that the body should not be reacting to. dermatitis usually appears as burning, itching, and dryness, among others, in a particular area of skin, where the condition originates. The skin can also become inflamed and red and it can also become irritated if touched, a type of pain that is most common among children, and the elderly. Dermatitis causes pain and discomfort and, in the most severe or chronic forms, can cause health problems that can lead to death if not treated." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of branebrutinib?

"Branebrutinib has a broad spectrum of side effects; it can cause gastrointestinal disorders (including diarrhea, abdominal pain, and nausea), skin and subcutaneous tissues irritation, headache, dizziness, vomiting, constipation and dyspnea." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for dermatitis?

"Clinical trials do not offer a reliable way to predict who will [participate in trials of new treatments, or fail to improve, after treatment in clinical practice] obtain a benefit from new treatments, but they do offer an opportunity to help determine who best needs treatment. In light of this we argue that there is an urgent need to [consider applying to clinical trials for dermatitis with caution]." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of dermatitis?

"Most dermatitis cases were secondary to [environmental factors, including cosmetics, medications, and exposures to infectious agents and chemicals as well as allergic reactions to contact with skin]. Primary causes of dermatitis that need to be taken into account while making a definitive diagnosis include skin contact infections." - Anonymous Online Contributor

Unverified Answer

Is branebrutinib safe for people?

"Both the safety and pharmacokinetics of branebrutinib were similar to those in the placebo/Bratu cohort. Branebrutinib is safe to use in people with relapsed or refractory multiple myeloma." - Anonymous Online Contributor

Unverified Answer

How does branebrutinib work?

"Although the mechanism of action for branebrutinib isn't known, clinical responses are seen in patients, even subjects who have never been treated before, and branebrutinib represents an invaluable therapy for some patients with rituximab-refractory Waldenström macroglobulinemia." - Anonymous Online Contributor

Unverified Answer

Is branebrutinib typically used in combination with any other treatments?

"Branebrutinib is predominantly used in combination with at least one other treatment, with no clear indication for which treatment is used. In patients with ALK-positive metastatic non-small cell non-small cleaved lung cancer, the optimal combination regimen has not been established." - 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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