Rilzabrutinib for Eczema, Infantile

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Antelope Valley Clinical Trials-Site Number:8400001, Northridge, CA
Eczema, Infantile+3 More
Rilzabrutinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

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

See full description

Eligible Conditions

  • Eczema, Infantile
  • Dermatitis, Dermatitis Atopic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Eczema, Infantile

Study Objectives

This trial is evaluating whether Rilzabrutinib will improve 1 primary outcome and 10 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of From baseline to Week 16.

At Week 16
Proportion of participants achieving EASI-50/90
Proportion of participants achieving EASI-75
Proportion of participants with Investigator's Global Assessment (IGA) of 0 or 1 (disease free or almost disease free) compared to placebo
Week 16
Absolute change in EASI score
Change in percent body surface area (BSA) of EASI.
Change on weekly average of daily PP-NRS.
Incidence of study investigational medicinal product (IMP) discontinuation and withdrawals due to TEAEs
Percent change in Eczema Area and Severity Index (EASI) score
Proportion of participants with reduction of weekly average of daily peak pruritus Numerical Rating Scale (PP-NRS) of ≥4 points
Until Week 16
Time to onset of effect on pruritus
Up to Week 17
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Eczema, Infantile

Trial Design

2 Treatment Groups

Rilzabrutinib
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Rilzabrutinib 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 2 and have already been tested with other people.

Rilzabrutinib
Drug
Rilzabrutinib BID or TID
Placebo
Drug
Matching placebo

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 17
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to week 17 for reporting.

Closest Location

Antelope Valley Clinical Trials-Site Number:8400001 - Northridge, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
AD as defined by the American Academy of Dermatology Consensus Criteria.
History of AD for at least 12 months prior to baseline as determined by the Investigator through patient interview.
Eczema Area and Severity Index (EASI) score ≥ 12 at screening and ≥ 16 at baseline.
IGA score ≥ 3 (on the 0 to 4 IGA scale) at baseline.
BSA of AD involvement ≥ 10% at baseline.
Documented inadequate response or intolerance to TCS within 6 months prior to baseline visit
Baseline PP-NRS score for maximum itch intensity ≥4.
All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
For optional substudy only: Willingness to have 2 tape strips for comparison of baseline and treatment response.

Patient Q&A Section

What is the latest research for eczema, infantile?

"A 2014 systematic review reported on the most recent research, comparing the efficacy and safety of oral miconazole with the more traditional regimen of topical miconazole for the treatment of infants less than 6 months of age suffering from dry, scaly, atopic dermatitis"" - Anonymous Online Contributor

Unverified Answer

What are common treatments for eczema, infantile?

"This population-based study confirms the frequency of atopic disorders, including eczema, allergic rhinitis and allergic asthma, but it does not prove a genetic relationship between them. Moreover, it reveals that topical and systemic therapy constitute the cornerstone of the management of these conditions. For example, several treatments for eczema offer significant therapeutic advantages compared to systemic therapy." - Anonymous Online Contributor

Unverified Answer

What causes eczema, infantile?

"Eczema, infantile is one of the most common and challenging problems in general pediatric dermatology. Most eczema is triggered by environmental factors. This article describes what researchers know about the causes of eczema, infantile." - Anonymous Online Contributor

Unverified Answer

How many people get eczema, infantile a year in the United States?

"Results from a recent clinical trial suggests that eczema occurs at about the same rate year round in the United States. Eczema has a higher prevalence in early ages. The prevalence of eczema in the United States remains relatively stable. Eczema is not a life span disease but it has been shown to result in an important reduction of quality of life. Patients who suffer from a chronic disease like eczema need treatment that will provide relief and improve quality of life." - Anonymous Online Contributor

Unverified Answer

What are the signs of eczema, infantile?

"Eczema in infants and young children can present with a dry, red, scaly and itching-associated rash. It often accompanies a dry, scaly or itchy diaper rash. Eczema can also cause skin damage which can cause serious infection or skin breakdown.\n" - Anonymous Online Contributor

Unverified Answer

Can eczema, infantile be cured?

"Eczema can be avoided and cured with effective hygiene measures and a low-toxic, high-favorability approach to the treatment of eczema. There is no "can't cure eczema" but only "can't treat eczema" because of the difficulty of reaching the exact source of the disease from which the eczematous pathophysiology has developed." - Anonymous Online Contributor

Unverified Answer

What is eczema, infantile?

"Eczema, infantile involves itching, redness and oily skin, but is not usually associated with atopic tendencies. The condition rarely goes away without treatment and affects 3% of the British population.\n" - Anonymous Online Contributor

Unverified Answer

What are the latest developments in rilzabrutinib for therapeutic use?

"rilzabrutinib as an allosteric, potent inhibitor of JAK1-dependent signaling. It inhibits downstream signaling by blocking STAT tyrosine phosphorylation. It inhibits T cell proliferation, inhibits tumor cell survival, and induces T cell-dependent cytotoxicity." - Anonymous Online Contributor

Unverified Answer

Does rilzabrutinib improve quality of life for those with eczema, infantile?

"Rilzabrutinib was well tolerated and led to significant improvement in the patients' quality of life scores. The benefit was sustained for at least 12 months." - Anonymous Online Contributor

Unverified Answer

Is rilzabrutinib typically used in combination with any other treatments?

"The most common comorbidity reported in the trials was dyslipidemia. The most common comorbidities reported in these trials were pulmonary disorders (17%) and dermatologic disorders (12%), which are similar to common comorbidities of people suffering from rheumatoid arthritis. In a post hoc analysis, no statistically significant association was demonstrated between riluzole use and the development of dyslipidemia or lipoprotein (a) levels. Because riluzole may have efficacy against many chronic inflammatory diseases, riluzole may be considered a reasonable alternative treatment in select patients for those who must take other medications to treat their chronic inflammatory disease." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of eczema, infantile?

"Most experts agree that an imbalance of T helper-1 (Th1) cells and regulatory T cells plays a crucial role in eczema development. It is believed that eczema in babies can be triggered by excessive maternal Th2 cytokine production. The high levels of Th2 cytokines secreted by mothers are associated with eczema in their children. Furthermore, maternal eczema has been shown to be more likely if there is a maternal family history of eczema. Therefore, eczema, infantile can be induced in non-immune eczema mother by environmental factors." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving rilzabrutinib?

"Rilzabrutinib is a new FDA approved drug indicated for patients with moderate, moderate-to-severe or severe (PASI60 or PASI90), stable or recurrent cutaneous psoriasis. There are currently two prospective, open-label trials – one in pediatric patients with acute cutaneous lupus erythematosus and one in adult patients with moderate to severe plaque psoriasis that have failed other therapies. It is currently in the pre-market approval phase. Rilzarutinib failed to meet the primary endpoint of inhibiting PASI75 (≥ 75%) in adult patients with psoriasis from the SPIRIL program at the end of April 2012." - 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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