CC-93538 for Eczema, Infantile

Phase-Based Estimates
Dermatologicka Ambulance MUDr. Petr Trestik, Svitavy, Czechia
Eczema, Infantile+2 More
CC-93538 - Drug
All Sexes
Eligible conditions
Eczema, Infantile

Study Summary

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

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Eligible Conditions

  • Eczema, Infantile
  • Dermatitis, Atopic
  • Eczema
  • Dermatitis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CC-93538 will improve 1 primary outcome and 11 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of Up to week 16.

Up to week 16
Mean change in SCORAD Scores from Baseline at Week 16
Percent change from Baseline in Pruritus Numerical Rating Scale (NRS) at Week 16
Percent change in BSA involved with AD from baseline at Week 16
Percent change in EASI from Baseline at Week 16
Proportion of participants with Pruritus NRS change of ≥ 4 points from Baseline at Week 16
Proportion of participants with an vIGAAD score from Baseline at Week 16
Proportion of participants with at least a 75% improvement from Baseline in Eczema Area and Severity Index (EASI-75) at Week 16
Proportion of participants with at least a 90% improvement from Baseline in Eczema Area and Severity Index (EASI-90) at Week 16
Time to achieve at least 4 points of improvement in the severity of pruritus NRS scale in the first 16 weeks of treatment
Up to week 32
Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538
Incidence of Adverse Events (AEs)

Trial Safety

Safety Estimate

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

Trial Design

4 Treatment Groups

Placebo SC QW
Dose 1: CC-93538 SC QW
Placebo group

This trial requires 214 total participants across 4 different treatment groups

This trial involves 4 different treatments. CC-93538 is the primary treatment being studied. Participants will be divided into 3 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.

Dose 1: CC-93538 SC QW
Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks.
Dose 3: CC-93538 and Placebo SC Q2WStarting at the baseline visit, active IP and matching placebo will be administered. On the alternate weeks, placebo will be administered weekly to maintain the blind.
Dose 2: CC-93538 and Placebo SC Q2WStarting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind.
Placebo SC QW
Administration of placebo each week.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 32
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to week 32 for reporting.

Closest Location

Local Institution - 213 - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Body Surface Area (BSA) ≥ 10%,
EASI score ≥ 16,
vIGA-AD ≥ 3,
Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.
Participant must commit to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
Participants currently receiving concomitant medications for any reason other than AD, such as inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast), or mast cell stabilizers (eg, cromolyn sodium) for asthma, must be on a stable regimen, which is defined as not starting a new drug, changing, or stopping dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the treatment duration of the study.
Participant must be ≥ 18 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF).
Participant has chronic atopic dermatitis (AD) as defined by Hanifin and Rajka that has been present for ≥ 1 year prior to the baseline visit (Day 1).
Participant must have a documented history of inadequate response to treatment with topical medications for at least 4 weeks, unless topical treatments are otherwise medically inadvisable or has required systemic therapy for control of disease.
Participant must be willing to apply a stable dose of topical emollient (eg, over-the-counter moisturizer, non-medicated emollient, etc.) twice daily for ≥ 7 days prior to the Baseline visit and continue application throughout the study.

Patient Q&A Section

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

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

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The prevalence of eczema, infantile in the US is 6.1%, higher than those studied with the U.S. NHANES in 1988 of 4.4%. The rate in 2005-2006 in a large metropolitan clinic in the USA is 7.1% with an estimated lifetime prevalence of 2.4% or an estimated prevalence of 6.11% per person. This appears to be the first study utilizing a broad definition of eczema, infantile. As for allergic rhinitis, 2% of patients in children as per the national study reported experiencing it and 1% reported having it last year. There was no significant difference in reporting between patients with atopic and nonatopic eczema.

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What are common treatments for eczema, infantile?

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Eczema tends to be persistent despite medications, and many patients seek a referral from their doctor, who may prescribe immunosuppressive agents (such as tacrolimus) or topical steroids. For those who are allergic to corticosteroids, alternative products with less or no steroid (e.g., topical cortisone) are often prescribed.

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What are the signs of eczema, infantile?

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Eczema, infantile is a generalized condition with several different manifestations. We are only able to summarize and compare a few signs that can happen with any of the different forms of eczema, infantile. See Eczema symptoms and Signs.. There is no known or effective cure for eczema, infantile, for either adults or children. Doctors' attention will help to provide more information about the various forms of eczema, infantile.

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What causes eczema, infantile?

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There is an increasing recognition that multiple factors are involved in the pathogenesis of eczema and must be identified and treated as early as possible. There may be multiple 'injury mechanisms' operating.

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Can eczema, infantile be cured?

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Despite early recognition of eczema, a cure is not likely. Eczematous individuals are probably predisposed to infection, requiring regular and stringent hand washing and careful medical management.

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What is eczema, infantile?

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Eczema is a chronic inflammatory skin disorder with different subtypes ranging from mild and mild to severe and severe form of the disease. Infantile eczema affects 5-10 percent of children in Europe and 2-4 percent in the US. Patients present with scaling on the skin, redness, itching, burning, pain, and sometimes swelling from inflammation. Some forms of the disease can affect the eyes, mucous membranes, nose, or throat. Treatment for infantile eczema often consists of topical steroids and topical hydrocortisone creams. Patients may need to repeat the treatment over time as the child grows.

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Have there been any new discoveries for treating eczema, infantile?

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Newer discoveries are bringing about changes in the treatment of eczema and we hope that these advances will also offer a new hope for an infantile that needs a solution as well.

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What is the primary cause of eczema, infantile?

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The most commonly cited causes of eczema infantile include [atopy & contact dermatitis & chemical irritant contact dermatitis / occupational contact dermatitis] are not the only likely triggers. Other environmental factors may play a role in eczema infantile.

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What is cc-93538?

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A novel class of synthetic, first-in-class, small molecule CCR2/CCL2 receptor modulators is described that inhibits a range of important immune, inflammatory, and allergic responses. This includes inhibition of T cell activation, IgE receptor-dependent mast cell degranulation, inflammatory cell infiltration, CCL2-driven leukocyte recruitment, and allergic symptom-reactivity. In addition, a novel CCR2-specific monoclonal antibody and synthetic small molecule CC-93538 are shown to inhibit the responses induced by specific inflammatory mediators such as IL-1β, interleukin-6, and IL-13.

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Have there been other clinical trials involving cc-93538?

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The most common side effects of cc-93538 are headache and rash, which may occur because of its mechanism of action. However, most patients were still able to complete the study. If it were to be used therapeutically, the main advantage would be its improved toxicity profile relative to other second generation H 3 receptors antagonists. However, the clinical trial in which it was tested did not demonstrate superiority over the second generation H 3 receptor antagonists.

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How does cc-93538 work?

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We used cc-93538 to prove that c-Kit plays an important role for the development of human airway epithelial cells. The PI3K/Akt pathway is involved in the regulation of the expression of the c-Kit receptor on human airway epithelial cells. Therefore, PI3K/Akt signaling may be a novel target to inhibit epithelial-mesenchymal transformation in pulmonary fibrosis by blocking cc-93538.

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What are the latest developments in cc-93538 for therapeutic use?

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The newly developed bivalirudin and apixaban derivatives appear to be potent inhibitors for thrombin and FXa that may have a role for future antithrombotic therapy. The new derivatives may also provide insights into the thrombin receptor and FXa receptor activation and inhibition and the function of the thrombin clotting time.

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