BSI-045B + Dupilumab for Eczema

(ADAMANT Trial)

Recruiting at 17 trial locations

Overseen By Chu Zhang, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biosion, Inc.

Must not be taking: Corticosteroids, Antihistamines

Disqualifiers: Cancer, Neurologic abnormalities, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BSI-045B, either alone or with another drug called dupilumab, in patients with moderate to severe atopic dermatitis. Dupilumab is a treatment option newly licensed for adolescents with moderate to severe atopic dermatitis (AD). The treatment involves regular injections, aiming to reduce inflammation and skin symptoms.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that oral antibiotics are allowed and bleach baths are not permitted. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug BSI-045B + Dupilumab for eczema?

Dupilumab, a part of the treatment, is known to be effective for eczema as it blocks certain proteins (IL-4 and IL-13) that cause inflammation. It has been approved for treating moderate to severe eczema and has shown success in reducing symptoms in various studies. ^{1 2 3 4 5}

Is the combination of BSI-045B and Dupilumab safe for treating eczema?

Dupilumab, used for treating eczema, has been shown to be generally safe in humans, with common side effects including injection site reactions, conjunctivitis (eye inflammation), headache, and nasopharyngitis (cold-like symptoms). Studies indicate its safety profile is similar to a placebo, meaning it doesn't cause more side effects than a sugar pill. ^{1 2 6 7 8}

How is the drug BSI-045B + Dupilumab different from other eczema treatments?

BSI-045B combined with Dupilumab is unique because Dupilumab is a monoclonal antibody that targets the IL-4Rα subunit, blocking key pathways involved in the inflammatory response of eczema. This combination may offer a novel approach by potentially enhancing the effects of Dupilumab, which is already approved for moderate-to-severe eczema. ^{1 4 5 6 9}

Research Team

James Appel, MD

Principal Investigator

wilmington health

Eligibility Criteria

Adults aged 18-65 with moderate to severe atopic dermatitis (AD) can join this trial. They must have an Eczema Area and Severity Index (EASI) score of ≥12, affected body surface area (BSA) ≥10%, and an Investigator's Global Assessment (IGA) score of ≥3. Participants should agree to use effective contraception if applicable. Those on stable dupilumab therapy but still with active AD may also qualify for add-on therapy cohorts.

Inclusion Criteria

Your skin condition is rated as moderate or severe on the IGA scale during screening and on day 1.

The patient signs and dates a written ICF prior to the initiation of any study procedures.

I have active disease despite treatment or haven't received any treatment.

Exclusion Criteria

The patient has a history of allergy to specific medications.

I have had a serious infection within the last month.

I have a skin condition that could affect my eczema diagnosis or treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BSI-045B 300 mg SC weekly for 4 weeks, then every 2 weeks through Week 24

24 weeks

Weekly visits for the first 4 weeks, then bi-weekly visits until Week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits as needed for safety assessments

Treatment Details

Interventions

• BSI-045B
• Dupilumab

Trial Overview The study tests BSI-045B as a solo treatment or alongside dupilumab in people with AD. It has four groups: two will receive different doses of BSI-045B alone, and two will get these doses plus ongoing dupilumab treatment. The drug is given weekly for three weeks, then every other week up to Week 24.

Participant Groups

Group I: 300 mg Experimental Treatment 1 Intervention

BSI-045B 300 mg SC QW × 4 weeks, then BSI-045B 300 mg SC Q2W through Week 24

Who Is Running the Clinical Trial?

Biosion, Inc.

Lead Sponsor

Trials

2

Recruited

80+

Findings from Research

In a phase III study involving 165 adult Chinese patients with moderate-to-severe atopic dermatitis, dupilumab significantly improved skin condition, with 26.8% of patients achieving the primary efficacy endpoint compared to only 4.8% in the placebo group (P < 0.001).

Dupilumab demonstrated a favorable safety profile, although there was a higher incidence of conjunctivitis and injection site reactions compared to placebo, indicating that while effective, monitoring for these side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of dupilumab in Chinese patients with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled study. Zhao, Y., Wu, L., Lu, Q., et al.[2022]

Dupilumab is a monoclonal antibody that specifically targets the IL-4Rα subunit of IL-4 and IL-13 receptors, effectively blocking the signaling pathways of these cytokines involved in type 2 inflammation.

Approved in March 2017 for atopic dermatitis, dupilumab offers a targeted treatment option for eczema by reducing the inflammatory response associated with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL-4Rα Inhibitor for Atopic Disease. Chang, HY., Nadeau, KC.[2019]

In a study of 818 adults with moderate-to-severe atopic dermatitis treated with dupilumab for at least 16 weeks, 12% of patients successfully spaced their doses or withdrew treatment while still maintaining effectiveness.

Key predictors for successful dose spacing or treatment withdrawal included having non-cutaneous atopic manifestations, a prurigo nodularis phenotype, and being older at the start of treatment, suggesting specific patient profiles can benefit from adjusted treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. Chiricozzi, A., Dal Bello, G., Gori, N., et al.[2023]

Dupilumab, an IL-4 receptor antagonist, is the first FDA-approved biological therapy for moderate-to-severe atopic dermatitis (AD) and has shown improved outcomes in patients inadequately controlled by topical treatments.

However, this case report highlights new side effects, specifically hyperhidrosis and bromhidrosis, in two patients after starting dupilumab, suggesting the need for further research on its long-term safety and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis. Rowane, M., Valencia, R., Schend, J., et al.[2022]

Dupilumab significantly improved symptoms of atopic dermatitis (AD) in both adults (n=3,817) and children/adolescents (n=618), showing a marked reduction in the Eczema Area Severity Index (EASI) score and pruritus, indicating its efficacy as a treatment option.

The safety profile of dupilumab was comparable to that of a placebo, with no increase in adverse events, suggesting it is a safe option for managing AD-related symptoms and improving patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. Koskeridis, F., Evangelou, E., Ntzani, EE., et al.[2022]

In a study of 69 patients with moderate to severe atopic dermatitis (AD) who were not responding adequately to dupilumab alone, 12 patients received additional treatments, such as methylprednisolone or phototherapy, and 11 of them showed significant improvement after 8 weeks.

The combination therapy was well-tolerated, with no adverse events reported, suggesting that adding conventional drugs or phototherapy to dupilumab can be a safe and effective option for patients struggling with treatment-resistant AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Combination of Systemic Agents for the Treatment of Atopic Dermatitis Resistant to Dupilumab Therapy. Gori, N., Chiricozzi, A., Malvaso, D., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of dupilumab in Chinese patients with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled study. [2022]

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

Severe eczema in Wiskott-Aldrich syndrome-related disorder successfully treated with dupilumab. [2023]

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

The emerging role of dupilumab in dermatological indications. [2022]

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

IL-4Rα Inhibitor for Atopic Disease. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [2023]

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

Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis. [2022]

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

Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Successful Combination of Systemic Agents for the Treatment of Atopic Dermatitis Resistant to Dupilumab Therapy. [2021]

9. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy of dupilumab in atopic comorbidities associated with moderate-to-severe adult atopic dermatitis. [2021]