What side effects are associated with this type of intervention?

Common treatments for allergies, such as sublingual allergen immunotherapy (SLIT), can cause side effects including throat irritation, swelling of the lips, tongue, and pharynx, and oral mucosal pruritus. These reactions are typically mild to moderate and self-limited, often resolving within one to two weeks of continued therapy. More severe reactions, such as transient angioedema, may occur but are less common. In rare cases, severe oropharyngeal reactions may necessitate the use of epinephrine and discontinuation of therapy. These side effects are important considerations for treatments aimed at preventing or reducing allergic reactions, including atopic dermatitis.

What prior FDA approvals exist?

FDA-approved treatments for allergies, particularly those aimed at preventing or reducing allergic reactions like atopic dermatitis, include biologics such as omalizumab (Xolair). Omalizumab is a monoclonal anti-IgE antibody used for severe allergic asthma and chronic spontaneous urticaria, showing efficacy in reducing symptoms and improving quality of life. Additionally, sublingual immunotherapy (SLIT) tablets for allergens like grass pollen and house dust mites have been approved to treat allergic rhinitis and conjunctivitis, with some evidence suggesting they may reduce the risk of developing asthma. These treatments share a preventive approach similar to the investigational drug STMC-103H.

What other types of research exist?

Promising novel alternatives to STMC-103H for the prevention or reduction of allergic reactions, specifically atopic dermatitis, include: 1) Dupilumab, which has shown safety and efficacy in multiple phase III trials for moderate-to-severe atopic dermatitis. 2) VTP-38543 cream, which demonstrated improvements in skin barrier function and atopic dermatitis severity in a randomized controlled trial. 3) SDZ ASM 981 (Pimecrolimus), which has been effective in treating moderate atopic dermatitis in clinical studies. 4) E6005, a phosphodiesterase 4 inhibitor, which showed safety and efficacy in a randomized, vehicle-controlled trial in Japanese adults with atopic dermatitis.

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STMC-103H for Allergies (adored Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for allergies, such as immunotherapy, work by gradually desensitizing the immune system to specific allergens. This is achieved through controlled exposure to increasing doses of the allergen, which helps the body build tolerance and reduce hypersensitivity reactions. For instance, subcutaneous and sublingual immunotherapies are designed to modify the immune response, thereby preventing or reducing the severity of allergic reactions like atopic dermatitis. These treatments are crucial for allergy patients as they target the underlying immune mechanisms, potentially offering long-term relief and reducing the need for symptomatic medications.

Phase 1 & 2

Waitlist Available

Research Sponsored by Siolta Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject's parent(s)/legal representative(s) do not plan to give probiotics (including infant formula that contain probiotics) to the subject during the trial (Part A2)

Subject has a birthweight ≥ 2.5 kg and ≤ 4.5 kg (Part B)

Must not have

Subject is acutely ill or on systemic antibiotics at the time of enrollment

Subject was born at < 35 weeks' gestation (Part B)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at days 168, 336 and 672

Summary

This trial is testing a new treatment called STMC-103H to see if it can help prevent allergic diseases in young children. The study focuses on babies and infants who are at risk of developing allergies. The treatment aims to improve their immune system's response to allergens, potentially reducing conditions like atopic dermatitis.

Who is the study for?

This trial is for newborns and infants at risk of developing allergies, with family history of asthma or allergic conditions. It's not for those with congenital abnormalities, significant diseases, immune deficiencies, or born prematurely (<35 weeks' gestation). Participants must be between 28 days to less than 6 years old depending on the study part.

What is being tested?

The trial tests STMC-103H against a placebo in preventing allergy development. It has three parts: initial safety-run (28 days treatment), followed by review; then a larger group treated for almost a year. Safety and effectiveness are monitored through adverse events and diagnosis rates.

What are the potential side effects?

Potential side effects include reactions typical to new medications such as digestive issues, skin rashes, or respiratory symptoms. Serious side effects will be closely monitored including any impact on growth or overall health during the first year.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will not give my child probiotics during Part A2 of the trial.

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My birthweight was between 2.5 kg and 4.5 kg.

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My newborn is less than 14 days old.

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I am between 1 and 6 years old.

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My parent or legal guardian is over 18 and can give consent.

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My child will not receive probiotics from birth until the trial ends.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not currently very sick or on antibiotics.

Select...

I was born before reaching 35 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at days 168, 336 and 672

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at days 168, 336 and 672

This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 168, 336 and 672 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A1 and A2: Assess safety and tolerability of STMC-103H in children and infants at risk for development of allergic disease by assessing adverse events (AE), serious adverse events (SAE), and AEs of special interest

Part B: Assess the safety, tolerability of STMC-103H in neonate and infants subjects at risk for development of atopic disease by monitoring AEs, SAEs, AESI, physical exam findings, and clinical safety laboratories.

Dermatitis, Atopic

Secondary study objectives

Part B - Secondary Efficacy Endpoint - atopic disease assessments

Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts

Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma

+9 more

Other study objectives

Feces

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: STMC-103H Part BExperimental Treatment1 Intervention

Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days

Group II: STMC-103H Part A1Experimental Treatment1 Intervention

Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days

Group III: STMC-102H Part A2Experimental Treatment1 Intervention

Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days

Group IV: Placebo Part A1Placebo Group1 Intervention

Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days

Group V: Placebo Part BPlacebo Group1 Intervention

Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days

Group VI: Placebo Part A2Placebo Group1 Intervention

Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for allergies, such as immunotherapy, work by gradually desensitizing the immune system to specific allergens. This is achieved through controlled exposure to increasing doses of the allergen, which helps the body build tolerance and reduce hypersensitivity reactions. For instance, subcutaneous and sublingual immunotherapies are designed to modify the immune response, thereby preventing or reducing the severity of allergic reactions like atopic dermatitis. These treatments are crucial for allergy patients as they target the underlying immune mechanisms, potentially offering long-term relief and reducing the need for symptomatic medications.

How will we treat asthma in the year 2000?Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long-term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis.Specific allergen immunotherapy for the treatment of atopic eczema: a Cochrane systematic review.