BxC-I17e for Eczema
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Brexogen Inc.
Disqualifiers: Hepatitis, HIV, Pregnancy, Cardiac, others
Trial Summary
What is the purpose of this trial?This trial is testing a new treatment called BxC-I17e in patients with moderate to severe atopic dermatitis to see if it is safe and effective.
Will I have to stop taking my current medications?
The trial requires that you stop using topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI) at least one week before the study starts. Other medications are not specifically mentioned, so it's best to discuss with the study team.
What data supports the effectiveness of the treatment BxC-I17e for eczema?
The study on non-steroid treatments for eczema shows that new anti-inflammatory products can be effective in healing eczema, similar to Hydrocortisone Butyrate 0.1% Cream. Additionally, treatments like pimecrolimus and tacrolimus have been effective for atopic eczema, suggesting that non-steroid options can work well for this condition.
12345What safety data exists for BxC-I17e or similar treatments for eczema?
The anti-IL-17C antibody MOR106, which may be similar to BxC-I17e, was tested in several studies and found to be well-tolerated with a safety profile consistent with other approved treatments for eczema, although it was not effective for treating the condition.
36789Eligibility Criteria
Adults over 18 with moderate to severe atopic dermatitis (AD) for at least a year, who haven't responded well to standard creams or ointments. They must use fragrance-free moisturizers twice daily for a week before starting and be able to follow the study plan. Pregnant or breastfeeding women, those in other studies, with serious health issues, certain blood/lab abnormalities, HIV, or recent AD treatments are excluded.Inclusion Criteria
I have had moderate to severe atopic dermatitis for at least 1 year.
I have tried treatments for my skin condition without success.
I am 18 years old or older.
+3 more
Exclusion Criteria
I have skin conditions that could be mistaken for atopic dermatitis.
Pregnant or breastfeeding women
Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive single or multiple subcutaneous doses of BxC-I17e or placebo
8 weeks (single dose) or 14 weeks (multiple dose)
4 visits (in-person) for multiple dose group
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Participant Groups
The trial is testing BxC-I17e's safety and effectiveness against a placebo in one-time subcutaneous injections for people with stubborn eczema. It aims to see if this new treatment can help when regular therapies don't work.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: BxC-I17e (Single Dose)Experimental Treatment1 Intervention
* Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e
* Single dose on Day 1
Group II: BxC-I17e (Multiple Dose)Experimental Treatment1 Intervention
* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e
* 4 doses on Day 1, 15, 29, and 43
Group III: Placebo (Single Dose)Placebo Group1 Intervention
* Subcutaneous (SC) injection of the matching placebo
* Single dose on Day 1
Group IV: Placebo (Multiple Dose)Placebo Group1 Intervention
* Subcutaneous (SC) injection of the matching placebo
* 4 doses on Day 1, 15, 29, and 43
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
DermDox Centers for DermatologyCamp Hill, PA
Arkansas Research TrialsNorth Little Rock, AR
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Brexogen Inc.Lead Sponsor
References
Non steroid treatment for eczema: results from a controlled and randomized study. [2015]This study assesses the efficacy of a new non steroid anti-inflammatory product in comparison to Hydrocortisone Butyrate 0.1% Cream in healing eczematous dermatitis.
The effectiveness and cost-effectiveness of pimecrolimus and tacrolimus for atopic eczema: a systematic review and economic evaluation. [2019]To consider the effectiveness and cost-effectiveness of pimecrolimus for mild to moderate atopic eczema and tacrolimus for moderate to severe atopic eczema compared with current standard treatment in adults and children.
Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: a randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. [2023]Topical anti-inflammatory therapy is a cornerstone of treatment for atopic dermatitis (AD). However, many unmet needs remain with existing therapies. B244 is a live topical biotherapeutic being tested for the reduction of pruritus and improvement of eczema signs in patients with AD. We aimed to assess the safety and efficacy of B244, compared to vehicle, for patients with mild-to-moderate AD and moderate-to-severe pruritus.
Alitretinoin for the treatment of severe chronic hand eczema. [2018]This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of alitretinoin for the treatment of adults with severe chronic hand eczema refractory to topical steroid treatment in accordance with the licensed indication, based upon the evidence submission from Basilea Pharmaceuticals Ltd to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The clinical evidence came from a single placebo-controlled randomised controlled trial of daily treatment with alitretinoin for 12-24 weeks, with follow-up for a further 24 weeks, in patients with severe chronic hand eczema (CHE) unresponsive to topical steroids. A statistically significantly greater proportion of patients using alitretinoin achieved the primary end point of clear or almost clear hands by week 24 than did those with placebo. Dose-dependent headache was the most commonly reported adverse event in patients treated with alitretinoin. Serious adverse events were rare, but alitretinoin was associated with increases in both total cholesterol and triglycerides, which has implications for risks of future cardiovascular events. The manufacturer submitted a de novo decision analytic model to estimate, over a time horizon of 3 years, the cost-effectiveness of alitretinoin versus the other relevant comparators identified by NICE. In response to the points of clarification put to it by the ERG regarding the initial submission, the manufacturer provided additional evidence and a revised decision analytic model with a 'placebo' arm. In the manufacturer's original submission to NICE, the base-case incremental cost-effectiveness ratios (ICERs) reported for alitretinoin were 8614 pounds per quality-adjusted life-year (QALY) versus ciclosporin, -469 pounds per QALY versus psoralen + UVA (with alitretinoin dominant) and 10,612 pounds per QALY versus azathioprine. These ICERs decreased as the time horizon was extended in sensitivity analyses. In patients with hyperkeratotic CHE and in women of child-bearing potential, the ICER remained below 20,000. pounds When the health-related quality of life (HRQoL) values used in the model were replaced with those derived from an alternative study, these ICERs increased significantly (to 22,312 pounds per QALY for alitretinoin versus azathioprine). In the revised model, alitretinoin was reported to have an ICER of 12,931 pounds per QALY gained versus supportive care (placebo). However, the model underestimates the costs of treatment associated with alitretinoin. The manufacturer assumed that patients receiving alitretinoin visited the dermatologist every 4 weeks and ceased treatment as soon as they responded to it. If, in practice, patients would receive treatment for longer than this, then the manufacturer's model will have significantly underestimated the costs to the NHS. Additional analyses undertaken by the ERG produced ICERs close to 30,000 pounds per QALY gained for alitretinoin versus supportive care. This was largely due to uncertainty surrounding the impact of alitretinoin on HRQoL. The placebo-controlled trials conducted to date have established that alitretinoin can be efficacious for the treatment of severe CHE refractory to topical steroids, but longer term follow-up of trials or the implementation of registries is required to better establish the longer term efficacy or safety of alitretinoin. NICE recommended the use of alitretinoin for patients with severe CHE and a Dermatology Life Quality Index (DLQI) score of at least 15. Treatment was recommended to be stopped as soon as an adequate response was observed, or if CHE remained severe at 12 weeks, or if response was inadequate at 24 weeks.
Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema. [2015]This article describes the core outcome set (COS) for atopic eczema trials.
Phase 1 and 2 Randomized Clinical Studies Determine Lack of Efficacy for Anti-IL-17C Antibody MOR106 in Moderate-Severe Atopic Dermatitis. [2022]Interleukin 17C (IL-17C) modulates epithelial inflammation and has a possible role in atopic dermatitis (AD) pathology. Four randomized clinical studies (Phase 1 and 2) investigated the safety, tolerability, efficacy, and pharmacokinetic profile of the anti-IL-17C monoclonal antibody MOR106 for up to 12 weeks (NCT03568071: n = 207 adults with moderate-severe AD; NCT03689829 Part 1: n = 32 healthy males; NCT03689829 Part 2: n = 44 adults with moderate-severe AD; and NCT03864627: n = 76 adults with moderate-severe AD). In these studies, MOR106 was either administered intravenously (i.v.) every 2 or 4 weeks at doses between 1-10 mg/kg, or subcutaneously (s.c.), either as a single dose or doses every 2 weeks at 320 mg. Overall, MOR106 was well-tolerated, and the safety profile was consistent with monoclonal antibodies approved for AD. Bioavailability following s.c. dosing was 55%, and steady-state drug levels were reached at 2-4 weeks. Ongoing studies were terminated following a futility analysis of the Phase 2 placebo-controlled dose-finding study (NCT03568071) due to a low probability for achieving the primary efficacy endpoint. Cumulatively, MOR106 demonstrated ineffectiveness for the treatment of AD, but its safety and pharmacokinetic characteristics warrant further drug development in other indications. Funding: sponsored by Galapagos NV; funded by Novartis AG.
What's new in atopic eczema? An analysis of systematic reviews published in 2008 and 2009. [2022]This review summarizes clinically important findings from nine systematic reviews of the causes, treatment and prevention of atopic eczema (AE) published between August 2008 and August 2009. Two systematic reviews concluded that there is a strong and consistent association between filaggrin (FLG) mutations and development of eczema. The associations between FLG mutations and atopic sensitization, rhinitis and asthma are weaker than between FLG mutations and eczema, especially if those who also have eczema are excluded. The relationship between transforming growth factor levels in breast milk and eczema development is still unclear. A further systematic review found no strong evidence of a protective effect of exclusive breastfeeding for at least 3 months against eczema, even in those with a positive family history of atopy. Based on a systematic review and meta-analysis of six randomized controlled trials, supplementation with omega-3 and omega-6 oils is unlikely to play an important role in the primary prevention of eczema or allergic diseases in general. There is little evidence to support dietary restrictions of certain foods in unselected children with AE. There is also little evidence to suggest a clinically useful benefit from using probiotics in patients with established eczema. A systematic review of topical pimecrolimus and tacrolimus added little additional information to previous reviews, and did not provide any new data on long-term safety. Both of these drugs work in AE, and may reduce flares and usage of topical corticosteroids; however, there is still uncertainty about how they compare with topical corticosteroids.
What's new in atopic eczema? An analysis of systematic reviews published in 2009-2010. [2011]This review provides a summary of key findings from 18 systematic reviews on atopic eczema, published or indexed between January 2009 and 24 August 2010. There was no good evidence on the possible benefit of organic food consumption and eczema. Maternal intake of fish or fish oil may be associated with a reduced risk of eczema in offspring, although further studies are needed. There is some evidence that partially hydrolysed infant formulas rather than standard formulas may be associated with a reduced risk of eczema in infants, but there are shortcomings in the existing evidence. An inverse relationship has been found between gliomas/acute lymphoblastic leukaemia and allergic disease/eczema, but there appears to be no association between multiple sclerosis and eczema. Attention deficit hyperactivity disorder does appear to be associated with eczema, but there is no evidence of a causal link. The risk of eczema seems to be increased in urban compared with rural areas. Some new evidence has suggested superiority of 1% pimecrolimus over potent and mild corticosteroids at 6 months but not 12 months, and there is some evidence for superiority of 0.03% and 0.1% tacrolimus over 1% pimecrolimus. An updated Cochrane Review still found no evidence of a benefit from any form of antistaphylococcal treatment in managing clinically infected or uninfected eczema. The evidence base is poor for bath emollients, occlusive treatments (e.g., wet and dry wraps) and woven silk clothing in treating eczema. In general, the methods used in most systematic reviews of eczema need to be reported more clearly, especially with regard to a more vigorous quality assessment of included studies. Included studies are frequently heterogeneous, proxy reporting is common, and appropriate disease definitions are often lacking. Better adherence to existing guidance on trial reporting and prospective registration of clinical trials may help improve the quality of studies.
Characterizing real world safety profile of oral Janus kinase inhibitors among adult atopic dermatitis patients: evidence transporting from the rheumatoid arthritis population. [2022]To address potential safety concerns of Janus Kinase Inhibitors (JAK-Is), we characterized their safety profile in the atopic dermatitis (AD) patient population.