BxC-I17e for Eczema

Recruiting at 2 trial locations

Overseen By Shawna S Owens

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Brexogen Inc.

Disqualifiers: Hepatitis, HIV, Pregnancy, Cardiac, others

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks (single dose) or 14 weeks (multiple dose)

45 Participants Needed

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. ^{1 2 3 4 5}

What 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. ^{3 6 7 8 9}

Eligibility 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.

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

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

Treatment Details

Interventions

• BxC-I17e

Trial Overview 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.

Participant Groups

Group I: BxC-I17e (Single Dose) Experimental Treatment 1 Intervention

* Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e * Single dose on Day 1

Group II: BxC-I17e (Multiple Dose) Experimental Treatment 1 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 Group 1 Intervention

* Subcutaneous (SC) injection of the matching placebo * Single dose on Day 1

Group IV: Placebo (Multiple Dose) Placebo Group 1 Intervention

* Subcutaneous (SC) injection of the matching placebo * 4 doses on Day 1, 15, 29, and 43

Who Is Running the Clinical Trial?

Brexogen Inc.

Lead Sponsor

Trials

2

Recruited

50+

Findings from Research

In a pilot study involving Italian adults with eczema, the new non-steroid anti-inflammatory cream showed effectiveness in reducing eczema severity, with recovery rates of 58.3% in the non-steroid group compared to 91.7% in the Hydrocortisone group when following the treatment protocol closely.

While Hydrocortisone Butyrate 0.1% Cream was more effective overall, the non-steroid cream demonstrated significant clinical improvement at each assessment point, suggesting it could be a viable long-term treatment option for eczema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non steroid treatment for eczema: results from a controlled and randomized study. De Waure, C., Cadeddu, C., Venditti, A., et al.[2015]

Pimecrolimus is more effective than a placebo for treating mild to moderate atopic eczema, but there is limited evidence comparing it directly to topical corticosteroids, which are the current standard treatment.

Tacrolimus (both 0.03% and 0.1% formulations) is more effective than placebo and mild corticosteroids for moderate to severe atopic eczema, but shows no significant difference in effectiveness compared to potent topical corticosteroids, with common but mild side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and cost-effectiveness of pimecrolimus and tacrolimus for atopic eczema: a systematic review and economic evaluation. Garside, R., Stein, K., Castelnuovo, E., et al.[2019]

In a phase 2b trial involving 547 adults with mild-to-moderate atopic dermatitis, the topical biotherapeutic B244 significantly reduced pruritus by 34% compared to a placebo, demonstrating its efficacy as a treatment option.

B244 was well tolerated with no serious adverse events reported, and the incidence of mild treatment-emergent adverse events was low, indicating a favorable safety profile for this new therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Silverberg, JI., Lio, PA., Simpson, EL., et al.[2023]

Alitretinoin has been shown to be effective in treating severe chronic hand eczema (CHE) that does not respond to topical steroids, with a significant number of patients achieving clear or almost clear hands after 24 weeks of treatment in a placebo-controlled trial.

While alitretinoin is associated with some adverse effects, such as dose-dependent headaches and increases in cholesterol and triglycerides, it is considered cost-effective compared to other treatments, with an incremental cost-effectiveness ratio (ICER) of £12,931 per quality-adjusted life-year (QALY) gained versus supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alitretinoin for the treatment of severe chronic hand eczema. Paulden, M., Rodgers, M., Griffin, S., et al.[2018]

A core outcome set (COS) for atopic eczema trials has been established, emphasizing the need for standardized outcomes such as clinical signs, quality of life, symptoms, and long-term flare control to improve comparability across studies.

The Eczema Area and Severity Index is recommended as the primary tool for assessing clinical signs in these trials, ensuring that all studies measure outcomes in a valid and reliable manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema. Chalmers, J., Deckert, S., Schmitt, J.[2015]

The anti-IL-17C monoclonal antibody MOR106 was found to be well-tolerated in four clinical studies involving 207 adults with moderate to severe atopic dermatitis (AD), showing a safety profile similar to other approved monoclonal antibodies for AD.

Despite its safety and pharmacokinetic properties, MOR106 demonstrated ineffectiveness in treating AD, leading to the termination of ongoing studies after a futility analysis indicated a low probability of achieving the primary efficacy endpoint.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 and 2 Randomized Clinical Studies Determine Lack of Efficacy for Anti-IL-17C Antibody MOR106 in Moderate-Severe Atopic Dermatitis. Thaçi, D., Singh, D., Lee, M., et al.[2022]

Filaggrin (FLG) mutations are strongly linked to the development of atopic eczema, while their association with other allergic conditions like asthma and rhinitis is weaker, especially when excluding individuals with eczema.

There is insufficient evidence to support the effectiveness of exclusive breastfeeding, dietary restrictions, or omega-3 and omega-6 supplementation in preventing eczema, and while topical treatments like pimecrolimus and tacrolimus can help manage eczema, their long-term safety compared to corticosteroids remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's new in atopic eczema? An analysis of systematic reviews published in 2008 and 2009. Batchelor, JM., Grindlay, DJ., Williams, HC.[2022]

There is no strong evidence supporting the benefits of organic food consumption for atopic eczema, but maternal intake of fish or fish oil may lower the risk of eczema in children, indicating a potential area for further research.

1% pimecrolimus may be more effective than standard corticosteroids for eczema treatment at 6 months, while 0.03% and 0.1% tacrolimus show better results than pimecrolimus, highlighting the need for more rigorous studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's new in atopic eczema? An analysis of systematic reviews published in 2009-2010. Shams, K., Grindlay, DJ., Williams, HC.[2011]

In a study involving 261,855 patients with atopic dermatitis (AD), the safety profile of Janus Kinase Inhibitors (JAK-Is) was assessed by comparing health outcomes to a rheumatoid arthritis (RA) cohort of 5,296 patients, revealing that the incidence rates of health outcomes in the AD cohort were 13-50% lower than in the RA cohort.

The findings suggest that while the absolute risks of health outcomes in the AD population are higher than in the general population, JAK-Is may still present a safer profile for AD patients compared to those with RA, indicating a need for further validation in similar populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing real world safety profile of oral Janus kinase inhibitors among adult atopic dermatitis patients: evidence transporting from the rheumatoid arthritis population. Montez-Rath, ME., Lubwama, R., Kapphahn, K., et al.[2022]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Non steroid treatment for eczema: results from a controlled and randomized study. [2015]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness and cost-effectiveness of pimecrolimus and tacrolimus for atopic eczema: a systematic review and economic evaluation. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

Alitretinoin for the treatment of severe chronic hand eczema. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Phase 1 and 2 Randomized Clinical Studies Determine Lack of Efficacy for Anti-IL-17C Antibody MOR106 in Moderate-Severe Atopic Dermatitis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

What's new in atopic eczema? An analysis of systematic reviews published in 2008 and 2009. [2022]

8. England pubmed.ncbi.nlm.nih.gov

What's new in atopic eczema? An analysis of systematic reviews published in 2009-2010. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Characterizing real world safety profile of oral Janus kinase inhibitors among adult atopic dermatitis patients: evidence transporting from the rheumatoid arthritis population. [2022]