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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05003804
Registration number
NCT05003804
Ethics application status
Date submitted
4/08/2021
Date registered
12/08/2021
Date last updated
3/01/2024
Titles & IDs
Public title
Allergic Disease Onset Prevention Study
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Scientific title
A Phase 1b/2, Randomized, Double-blind, Placebo-controlled, Multi-center Study of STMC-103H in Neonates and Infants at Risk for Developing Allergic Disease
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Secondary ID [1]
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STMC-103H-102
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Universal Trial Number (UTN)
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Trial acronym
adored
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Type 1 Hypersensitivity
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - STMC-103H
Other interventions - Placebo
Experimental: STMC-103H Part A1 - Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Placebo Comparator: Placebo Part A1 - Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days
Experimental: STMC-102H Part A2 - Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
Placebo Comparator: Placebo Part A2 - Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days
Experimental: STMC-103H Part B - Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 336 days
Placebo Comparator: Placebo Part B - Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 336 days
Other interventions: STMC-103H
STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
Other interventions: Placebo
Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Frequency, type, and severity of AEs and SAEs, including AEs of special interest (AESI) as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale)
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Timepoint [1]
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Through 56 days of study
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Primary outcome [2]
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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.
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Assessment method [2]
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Frequency, type and severity of AEs, SAEs, and AESIs as in Appendix 9 (Adverse Events of Special Interest) and Appendix 10 (Adverse Event Grading Scale), as well as clinically significant findings on physical examinations including growth (length, weight, height and head circumference) and vital signs (RR, HR, and temperature); clinical safety laboratories including complete blood count with manual differential and blood chemistry
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Timepoint [2]
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Through 672 days of study
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Primary outcome [3]
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Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days
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Assessment method [3]
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Incidence of physician-diagnosed atopic dermatitis at 336 days in STMC-103H-treated subjects compared to placebo
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Timepoint [3]
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Day 336
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Secondary outcome [1]
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Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis
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Assessment method [1]
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Incidence of physician-diagnosed atopic dermatitis
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Timepoint [1]
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At days 168 and 672
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Secondary outcome [2]
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Part B - Secondary Efficacy Endpoint - atopic disease assessments
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Assessment method [2]
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Proportion of subjects who develop any atopic disease (atopic dermatitis, food allergy, allergic rhinitis/conjunctivitis, asthma)
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Timepoint [2]
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At days 168, 336 and 672
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Secondary outcome [3]
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Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen
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Assessment method [3]
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Incidence of sensitization to food and aeroallergen as measured by specific serum IgE levels
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Timepoint [3]
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At days 168, 336, and 672
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Secondary outcome [4]
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Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma
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Assessment method [4]
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Incidence of physician-diagnosed food allergy, allergic rhinitis/conjunctivitis, urticaria and wheezing illnesses/asthma using physician assessment, Allergic Disease Assessment and Diagnosis questionnaire, and Allergic Disease Diagnostic Criteria & Severity Evaluation
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Timepoint [4]
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At days 168, 336, and 672
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Secondary outcome [5]
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Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis
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Assessment method [5]
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Time to atopic dermatitis diagnosis by physician assessment
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Timepoint [5]
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Through 672 days of study
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Secondary outcome [6]
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Part B Secondary Efficacy Endpoint - Time to first wheezing episode
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Assessment method [6]
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Time to first wheezing episode by physician assessment
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Timepoint [6]
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Through 672 days of study
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Secondary outcome [7]
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Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment
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Assessment method [7]
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Severity of atopic dermatitis by IGAxBSA assessment
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Timepoint [7]
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At days 168, 336 and 672
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Secondary outcome [8]
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Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment
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Assessment method [8]
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Severity of atopic dermatitis by SCORAD assessment
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Timepoint [8]
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At days 168, 336 and 672
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Secondary outcome [9]
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Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma
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Assessment method [9]
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Severity of wheezing illness/asthma by Wheezing Severity Assessment
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Timepoint [9]
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At days 68, 336, and 672 days
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Secondary outcome [10]
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Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis
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Assessment method [10]
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Concomitant medications prescribed/used for allergic symptoms or diagnosis and use of rescue medications for atopic dermatitis and wheezing/asthma
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Timepoint [10]
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Through 672 days of study
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Secondary outcome [11]
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Part B Secondary Efficacy Endpoint - Total Serum IgE
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Assessment method [11]
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Total serum IgE levels
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Timepoint [11]
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At days 168, 336, and 672
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Secondary outcome [12]
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Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts
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Assessment method [12]
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Peripheral eosinophil counts by automated differential
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Timepoint [12]
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At day 336
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Eligibility
Key inclusion criteria
- All Parts (A1, A2, B)
1. Subject's parent(s)/legal representative(s) providing consent must be 18 years or
older
2. Biological mother and/or biological father and/or full sibling(s), have a history
of asthma, atopic dermatitis, food allergy, or allergic rhinitis as determined by
the screening questionnaire
3. Subject's parent(s)/legal representative(s) (if appropriate according to local
laws) is/are willing and able to give informed consent for participation in the
study
4. Subject's parent(s)/legal representative(s) (if appropriate according to local
laws) is/are willing and able, in the PI's opinion, to comply with all study
requirements
Part A1 Only
Inclusion criteria 1-4 for all parts plus:
5 (A1). Subject is between 1 year and < 6 years old at the time of enrollment
Part A2 Only
Inclusion criteria 1-4 for all parts plus:
5 (A2). Subject is between 28 days and < 12 months of life at the time of enrollment 6
(A2). 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 B Only
Inclusion criteria 1-4 for all parts plus:
5 (B). Subject is = 14 days of life at the time of enrollment. Sites should make every
effort to enroll newborns as soon as possible after birth.
6 (B). Subject has a birthweight = 2.5 kg and = 4.5 kg 7 (B). Subject's parent(s)/legal
representative(s) do not plan to give probiotics (including infant formula that contain
probiotics) to the subject from the time of birth to the end of the trial.
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Minimum age
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Maximum age
14
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- All Parts (A1, A2, B)
1. Subject's twin (or higher order multiple) is enrolled in STMC-103H-102
2. Subject has any congenital abnormalities or condition, significant disease,
illness, physical exam finding, or disorder that, in the opinion of the PI, may
put the subject at safety risk or is likely to hinder feeding or affect
metabolism that may influence the results of the study. (Neonatal
hyperbilirubinemia (jaundice), including jaundice that requires phototherapy,
should not be considered exclusionary).
3. Subject is acutely ill or on systemic antibiotics at the time of enrollment
4. 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
5. Subject has evidence of immune deficiency/immune compromise in the judgment of
the investigator
Part B Only
Exclusion Criteria 1-5 for all parts plus:
6 (B). Subject was born at < 35 weeks' gestation 7 (B). 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.)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2025
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Actual
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Sample size
Target
264
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [2]
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Queensland Children's Hospital - South Brisbane
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Recruitment hospital [3]
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The Women's and Children's Hospital - Adelaide
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Recruitment hospital [4]
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Monash Children's Hospital - Clayton
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Recruitment hospital [5]
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Murdoch Children's Research Institute - Parkville
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Recruitment hospital [6]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3052 - Parkville
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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Maryland
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Massachusetts
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Michigan
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New York
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Ohio
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South Carolina
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Texas
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Washington
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Wisconsin
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Puerto Rico
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State/province [17]
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Caguas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Siolta Therapeutics, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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 neonates and infants at risk
for developing allergic disease (Type 1 hypersensitivity). Subjects will be enrolled in a
three-part sequential approach. Participants in the safety-run portion of the study (Part A1:
1 year to <6 years of age and A2: 1 month to <12 months of age) will receive 28 days of
treatment with STMC-103H or placebo, followed by 28 days of follow-up. A Data and Safety
Monitoring Committee (DSMC) will review safety data after all patients in each part complete
28 days of therapy prior to enrolling the next part. After A2, Part B will enroll 224
patients for 336 days of treatment with STMC-103H or placebo, followed by 336 days of
follow-up. Stool, blood, and optional samples will be collected in Parts A2 and part B.
Primary safety endpoints are frequency, type and severity of Adverse Events (AEs) and Serious
Adverse Events (SAEs), as well as findings on physical exams, vitals, and safety
laboratories. The primary efficacy endpoint is incidence of physician-diagnosed atopic
dermatitis at day 336.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05003804
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05003804
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