STMC-103H for Allergies

(adored Trial)

Recruiting at 30 trial locations

Overseen By Brian Vickery, MD

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Siolta Therapeutics, Inc.

Compensation: Varies

Number of Visits: Unknown

264 Participants Needed

Trial Summary

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. 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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+