STMC-103H for Allergies

(adored Trial)

No longer recruiting at 31 trial locations

Overseen By Brian Vickery, MD

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Siolta Therapeutics, Inc.

Must not be taking: Systemic antibiotics

Disqualifiers: Congenital abnormalities, Immune deficiency, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, STMC-103H, for preventing allergies in infants and young children at risk of developing allergic conditions like eczema. Researchers aim to determine the treatment's safety and effectiveness by comparing it to a placebo (a harmless pill with no active treatment). The trial consists of several parts, with different groups of infants and children trying the treatment for varying lengths of time. A suitable candidate for this trial is a newborn or infant with a family history of allergies, such as asthma or eczema, and who will not receive probiotics during the study. As a Phase 1, Phase 2 trial, this study focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking allergy prevention research.

Will I have to stop taking my current medications?

The trial information does not specify if participants need to stop taking their current medications. However, participants cannot be on systemic antibiotics at the time of enrollment and cannot participate in another study with investigational medications within 30 days before this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that STMC-103H is under study to determine its safety and tolerance in children and infants who might develop allergies. In earlier studies with this group, researchers observed side effects to assess treatment tolerance. Reports so far suggest that STMC-103H is generally well-tolerated, with side effects similar to those from a placebo (a harmless, inactive substance used for comparison).

Additionally, other studies have tested STMC-103H in people with allergies, focusing on its safety compared to a placebo. These studies have not identified any major safety concerns. The treatment includes a mix of beneficial bacteria often missing in infants who later develop allergies, which is believed to help lower the risk of developing allergies.

While the safety data from these trials is encouraging, it's important to remember that this trial is still in an early stage. Researchers are still learning about the treatment's safety and effectiveness. As with any trial, participation involves careful monitoring by medical professionals to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for allergies?

Unlike the standard allergy treatments that typically involve antihistamines or corticosteroids, STMC-103H is distinctive because it offers a novel approach by combining the active ingredient with milk or milk products for administration. This unique delivery method might enhance the treatment's effectiveness or tolerability, especially for those who consume these products regularly. Researchers are excited about STMC-103H because it could offer a new way to manage allergies with potentially fewer side effects or interactions compared to traditional medications. Additionally, the extended dosing period of up to 336 days could provide long-term relief, which is appealing for chronic allergy sufferers.

What evidence suggests that STMC-103H might be an effective treatment for allergies?

Research has shown that STMC-103H, one of the treatments in this trial, might help prevent allergies in young children. Early studies suggest that this treatment is a probiotic, using beneficial bacteria to support the immune system. This could lower the risk of developing allergies like atopic dermatitis, a type of eczema. Previous patients demonstrated promising signs that STMC-103H can help manage allergy symptoms. Although more research is needed to confirm these results, the initial findings are encouraging for those at risk of allergies. Participants in this trial will receive either STMC-103H or a placebo to further evaluate its effectiveness. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My birthweight was between 2.5 kg and 4.5 kg.

My newborn is less than 14 days old.

Exclusion Criteria

Biological maternal medical condition during the pregnancy that, in the opinion of the PI, may put the subject at risk because of participation in the study. (Maternal antibiotics during the time of delivery should not be considered exclusionary) (Part B)

Subject is participating in another interventional clinical study involving investigational medication, formula, probiotic, or prebiotic use within 30 days (or five half-lives, whichever is longer) of this study

Subject's twin (or higher order multiple) is enrolled in STMC-103H-102

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A1 and A2

Participants receive STMC-103H or placebo for 28 days

4 weeks

Daily dosing

Follow-up Part A1 and A2

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Part B

Participants receive STMC-103H or placebo for 336 days

48 weeks

Daily dosing

Follow-up Part B

Participants are monitored for safety and effectiveness after treatment

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• STMC-103H

Trial Overview 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.

How Is the Trial Designed?

Group I: STMC-103H Part B Experimental Treatment 1 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 A1 Experimental Treatment 1 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 A2 Experimental Treatment 1 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 A1 Placebo Group 1 Intervention

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

Group V: Placebo Part B Placebo Group 1 Intervention

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

Group VI: Placebo Part A2 Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Siolta Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

320+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05003804

NCT05003804 | Allergic Disease Onset Prevention Study This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05003804

Allergic Disease Onset Prevention Study This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03819881

NCT03819881 | A Phase 1b Study of STMC-103H in Multi- ... A Phase 1b Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy. ClinicalTrials.gov ID NCT03819881.

4. withpower.com withpower.com/trial/phase-2-dermatitis-atopic-8-2021-5e025

STMC-103H for Allergies · Info for Participants What is the purpose of this trial? This trial is testing a new treatment called STMC-103H to see if it can help prevent allergic diseases in young children.

5. medresearch.umich.edu medresearch.umich.edu/labs-departments/centers/food-allergy/research/clinical-trials

Food Allergy Clinical Trials A phase 1b/2 study to evaluate the safety and efficacy of a probiotic (STMC-103H) in neonates and infants to prevent the development of allergic disease.

6. sioltatherapeutics.com sioltatherapeutics.com/pipeline/

Pipeline The potential of STMC-103H to prevent the onset of allergic diseases in ... safety and efficacy data in clinical trial subjects in support of potential regulatory ...

7. businesswire.com businesswire.com/news/home/20220726005014/en/Siolta-Therapeutics-Announces-First-Newborn-Dosed-in-Their-Phase-2-ADORED-Study-Evaluating-a-Potential-First-In-Class-Live-Biotherapeutic-Product-for-the-Prevention-of-Atopic-Diseases

Siolta Therapeutics Announces First Newborn Dosed in ... STMC-103H contains a combination of bacterial species that are depleted in the gut microbiota of infants who go on to develop allergic ...