FB825 for Eczema

Recruiting at 14 trial locations

Overseen By Jessica Ho

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oneness Biotech Co., Ltd.

Must be taking: Emollients

Must not be taking: Systemic corticosteroids, JAK inhibitors

Disqualifiers: HIV, Hepatitis B/C, Drug abuse, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy, pharmacokinetics, and Safety of repeat subcutaneous doses of FB825 in adults with moderate-to-severe atopic dermatitis.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting, such as systemic corticosteroids, cyclosporine, and other immunosuppressants, at least 4 weeks prior. You can continue using stable doses of non-sedative antihistamines.

What data supports the effectiveness of the drug FB825 for eczema?

While there is no direct data on FB825, other monoclonal antibodies like omalizumab have shown some effectiveness in treating atopic dermatitis (eczema), with 74.1% of patients experiencing a beneficial effect. This suggests that monoclonal antibodies can be effective for eczema, which may imply potential for FB825. ^{1 2 3 4 5}

Is FB825 safe for human use?

Monoclonal antibodies, like FB825, are generally considered well tolerated and relatively safe in humans, though they can cause some allergic reactions such as urticaria (hives) and other rare, serious side effects. It's important to monitor for any hypersensitive reactions during treatment. ^{1 2 6 7 8}

How does the drug FB825 for eczema differ from other treatments?

FB825 is a monoclonal antibody treatment that targets specific immune pathways involved in eczema, potentially offering a novel approach compared to existing treatments like corticosteroids or other monoclonal antibodies that target different immune components. ^{2 8 9 10 11}

Research Team

Chia-Yu Chu

Principal Investigator

National Taiwan University Hospital

Eligibility Criteria

Adults aged 18-65 with moderate-to-severe atopic dermatitis, who haven't responded well to topical treatments, can join this trial. They should have a history of the condition for at least 12 months and meet specific severity scores (EASI ≥16 and vIGA-AD ≥3). Participants must also have a significant area affected by eczema (>10% BSA) and experience intense itching.

Inclusion Criteria

My skin condition didn't improve after using strong skin creams for 4 weeks.

I weigh at least 40 Kg.

I have been diagnosed with severe skin eczema for over a year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive 5 subcutaneous doses of FB825 or placebo over 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• FB825

Trial Overview The study is testing FB825, a new medication given as repeat subcutaneous injections, against a placebo. The goal is to see if FB825 is effective in reducing symptoms of atopic dermatitis. This process involves randomly assigning participants to either the treatment or placebo group without them knowing which one they're receiving.

Participant Groups

Group I: FB825 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 2 Interventions

FB825 is already approved in United States, China for the following indications:

Approved in United States as FB825 for:

• Atopic Dermatitis

Approved in China as FB825 for:

• Allergic Asthma

Who Is Running the Clinical Trial?

Oneness Biotech Co., Ltd.

Lead Sponsor

Trials

21

Recruited

1,200+

Findings from Research

In a phase II study involving 79 Japanese patients with severe atopic dermatitis, ustekinumab (45 mg and 90 mg) did not show significant improvement in the Eczema Area and Severity Index (EASI) score compared to placebo after 12 weeks.

Despite the lack of meaningful efficacy, ustekinumab was generally well tolerated, with common side effects including nasopharyngitis and worsened atopic dermatitis, which were more prevalent in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ustekinumab in Japanese patients with severe atopic dermatitis: a randomized, double-blind, placebo-controlled, phase II study. Saeki, H., Kabashima, K., Tokura, Y., et al.[2022]

In a phase 1 study involving 22 patients with moderate to severe atopic dermatitis, KHK4083 was found to have an acceptable safety profile, with no serious adverse events or discontinuations due to side effects.

Patients showed sustained improvement in atopic dermatitis symptoms, as indicated by significant reductions in Eczema Area and Severity Index (EASI) and thymus and activation-regulated chemokine (TARC) levels over the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability and efficacy of repeated intravenous infusions of KHK4083, a fully human anti-OX40 monoclonal antibody, in Japanese patients with moderate to severe atopic dermatitis. Nakagawa, H., Iizuka, H., Nemoto, O., et al.[2021]

In a phase 2a study involving 113 adults with moderate to severe atopic dermatitis, tezepelumab showed a numerically greater efficacy compared to placebo, with 64.7% of patients achieving a ≥50% reduction in eczema severity (EASI50) at week 12.

The safety profile of tezepelumab was comparable to placebo, with similar rates of treatment-emergent adverse events, suggesting it is a safe option for patients when combined with topical corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial. Simpson, EL., Parnes, JR., She, D., et al.[2022]

In a case series of nine patients with atopic dermatitis treated off-label with omalizumab, 50% showed a good or excellent response, indicating potential efficacy for severe cases of the condition.

A systematic review of 26 studies involving 174 patients found that 74.1% experienced some level of benefit from omalizumab, suggesting it is generally safe and well-tolerated, although further research is needed to confirm its effectiveness in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab for atopic dermatitis: case series and a systematic review of the literature. Holm, JG., Agner, T., Sand, C., et al.[2022]

Allergic diseases are becoming more common and are primarily driven by the activation of mast cells and the subsequent inflammatory response, which includes eosinophils.

Recent advancements in treatment include monoclonal antibodies like omalizumab, which specifically target IgE and other molecules involved in allergic responses, offering new hope for patients with severe asthma and atopic dermatitis where traditional glucocorticosteroids may not be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monoclonal antibodies: the new magic bullets for allergy: IUPHAR Review 17. Landolina, N., Levi-Schaffer, F.[2022]

Monoclonal antibodies are generally well tolerated and considered safe for treating allergic rhinitis, based on a systematic review of 12 studies involving over 2600 patients.

While adverse events were not statistically significant overall, urticaria was identified as a notable risk, indicating that specific hypersensitive reactions should be monitored closely during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events for Monoclonal Antibodies in Patients with Allergic Rhinitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Lin, Y., Wang, W., Zhu, Z., et al.[2023]

Monoclonal antibodies (mAbs) have led to improved treatment outcomes for various diseases, with 110 mAb preparations approved for use, including 46 for cancers and 66 for non-cancer disorders, highlighting their efficacy in targeting specific disease-associated biomarkers.

Despite their targeted approach, mAbs can cause serious hypersensitivity reactions and adverse events, including anaphylaxis and severe infusion reactions, due to cytokine release, indicating the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune- and Non-Immune-Mediated Adverse Effects of Monoclonal Antibody Therapy: A Survey of 110 Approved Antibodies. Baldo, BA.[2022]

REGN1908-1909, a combination of two monoclonal antibodies targeting the cat allergen Fel d 1, demonstrated linear pharmacokinetics and dose-proportional increases in serum concentrations, with a single 600 mg dose maintaining effective levels for 8-12 weeks.

The treatment showed no dose-limiting toxicities and was safe, with adverse events not being dose dependent, indicating a favorable safety profile for potential use in adults with cat allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics. Kamal, MA., Dingman, R., Wang, CQ., et al.[2022]

Dupilumab shows a proportional increase in serum concentration with higher doses, indicating predictable pharmacokinetics, which is important for dosing strategies in treating conditions like atopic dermatitis.

The study found no need for dose adjustments based on ethnic origin or body weight, suggesting that dupilumab can be administered consistently across diverse populations without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab pharmacokinetics in Chinese healthy subjects and patients with atopic dermatitis: Results of two randomized, double-blind, placebo-controlled studies. Clot, PF., Kamal, M., Sun, J., et al.[2022]

In a phase III trial involving patients with moderate-to-severe atopic dermatitis, tralokinumab combined with topical corticosteroids showed significant efficacy, with 38.9% of patients achieving an Investigator's Global Assessment (IGA) score of 0/1 compared to 26.2% with placebo.

Tralokinumab was well tolerated, with a similar incidence of adverse events across treatment groups, indicating it is a safe option for patients needing systemic therapy for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Silverberg, JI., Toth, D., Bieber, T., et al.[2021]

In a study involving 11 allergic asthmatic subjects, the anti-IgE monoclonal antibody rhuMAb-E25 significantly increased the provocation concentration of allergens that could trigger asthma symptoms, indicating its potential efficacy in reducing asthma attacks.

rhuMAb-E25 was well tolerated with minimal side effects, leading to a substantial 89% reduction in serum-free IgE levels, which suggests it could be a promising new treatment for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory effects of an anti-IgE antibody E25 on allergen-induced early asthmatic response. Boulet, LP., Chapman, KR., Côté, J., et al.[2015]

References

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

Efficacy and safety of ustekinumab in Japanese patients with severe atopic dermatitis: a randomized, double-blind, placebo-controlled, phase II study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety, tolerability and efficacy of repeated intravenous infusions of KHK4083, a fully human anti-OX40 monoclonal antibody, in Japanese patients with moderate to severe atopic dermatitis. [2021]

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

Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial. [2022]

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

Omalizumab for atopic dermatitis: case series and a systematic review of the literature. [2022]

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

Monoclonal antibodies: the new magic bullets for allergy: IUPHAR Review 17. [2022]

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

Adverse Events for Monoclonal Antibodies in Patients with Allergic Rhinitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Immune- and Non-Immune-Mediated Adverse Effects of Monoclonal Antibody Therapy: A Survey of 110 Approved Antibodies. [2022]

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

REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Dupilumab pharmacokinetics in Chinese healthy subjects and patients with atopic dermatitis: Results of two randomized, double-blind, placebo-controlled studies. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. [2021]

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

Inhibitory effects of an anti-IgE antibody E25 on allergen-induced early asthmatic response. [2015]