BSI-045B + Dupilumab for Eczema

(ADAMANT Trial)

Recruiting at 19 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BSI-045B to evaluate its effectiveness for individuals with moderate to severe eczema, a skin condition causing irritation and itchiness. The study examines the treatment's safety, tolerability, and behavior in the body. Participants will receive injections weekly for the first month, then every two weeks for the next five months. Individuals who have had eczema for at least a year and have experienced symptoms for at least three months may be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that BSI-045B is likely to be safe for humans?

Research shows that BSI-045B is still under investigation to ensure its safety for humans. An early study with healthy adults tested BSI-045B for safety and tolerability, but detailed results are not yet available.

In contrast, Dupilumab, used with BSI-045B in the trial, has already received approval for treating eczema and is generally considered safe. Common side effects of Dupilumab include injection site reactions and occasional eye inflammation, such as pink eye.

Since the current study of BSI-045B is in the early testing phase, its safety profile is still being established. This stage is crucial for understanding how well people with eczema can tolerate BSI-045B. Participants in the study will provide important data on its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BSI-045B is unique because it offers a fresh approach to treating eczema by targeting specific pathways in the immune system. Most treatments for eczema, like topical steroids or calcineurin inhibitors, focus on reducing inflammation on the skin's surface. However, BSI-045B, when combined with Dupilumab, works differently by potentially modulating the immune response more precisely, which may lead to better long-term control of symptoms. Researchers are excited about this treatment because it could provide a new option for patients who do not respond well to existing therapies.

What evidence suggests that BSI-045B + Dupilumab could be an effective treatment for eczema?

Research shows that BSI-045B could be a promising treatment for eczema. Earlier studies found that BSI-045B, which targets a protein linked to inflammation, helped people with atopic dermatitis, a type of eczema. Patients experienced improvements in their skin and a decrease in symptoms. Initial trials demonstrated that BSI-045B was generally safe and well-tolerated. This treatment aims to lower the immune response that causes eczema, offering a new option for those with moderate to severe cases. ^{1 2 3 6 7}

Who Is on the Research Team?

James Appel, MD

Principal Investigator

wilmington health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Aclaris Therapeutics, Inc.

Lead Sponsor

Trials

35

Recruited

4,900+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05932654

NCT05932654 | POC Study to Evaluate BSI-045B in ... The study is a multicenter clinical trial and is designed as a proof-of-concept study to evaluate the efficacy, safety, tolerability, PK, immunogenicity, ...

2. academic.oup.com academic.oup.com/bjd/article-abstract/191/Supplement_2/ljae266.090/7728647

717 | British Journal of Dermatology | Oxford Academic 717 - Clinical efficacy, safety, and pharmacokinetic profile of bosakitug (BSI-045B), an anti-thymic stromal lymphopoietin (TSLP) mAb in a phase ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/biosion-bsi045b-atopic-dermatitis/

Biosion's plans on track with initiation of Phase IIa trial in ... According to Biosion, the results from the Phase I trial demonstrated BSI-045B to be a first-in-class treatment for AD due to the single dose ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05932654/poc-study-to-evaluate-bsi-045b-monotherapy-and-bsi-045b-add-on-therapy-with-dupilumab-in-atopic-dermatitis

POC Study to Evaluate BSI-045B in Moderate-to-severe ... This study is a Phase 2a, proof-of-concept clinical study designed to evaluate the efficacy, safety, tolerability, PK, immunogenicity, and PD of BSI-045B ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05114889

Safety and Tolerability of BSI-045B in Healthy Adult ... This study is a phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, PK profile, activity, and PD of BSI-045B injection after single/ ...

6. investor.aclaristx.com investor.aclaristx.com/news-releases/news-release-details/aclaris-therapeutics-announces-exclusive-global-license

Press Release - Investor Overview - Aclaris Therapeutics BSI-045B is currently in clinical development, and its safety and efficacy have not been evaluated by regulatory authorities. About BSI-502. BSI ...

7. withpower.com withpower.com/trial/phase-2-dermatitis-atopic-6-2023-432db

BSI-045B + Dupilumab for Eczema · Info for Participants Dupilumab, used for treating eczema, has been shown to be generally safe in humans, with common side effects including injection site reactions, conjunctivitis ...