Atopic Immunoglobulin E-Mediated Allergic DisorderPhase 1NCT03819881
A Phase 1b Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy
A Phase 1 study testing STMC-103H in people with Atopic Immunoglobulin E-Mediated Allergic Disorder, run by Siolta Therapeutics, Inc. at 2 sites in United States.
Trial summary
The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy. Read more about this study
- Who is it for?
- Ages 2 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Immunoglobulin E-Mediated Allergic Disorder
- What is being tested?
- STMC-103H
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2018to Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Voluntary informed consent from subject or legally acceptable representative and/or child assent from the subject (as applicable).
- For part 1, subjects of 18 years to 40 years of age at the timing of the signature on the informed consent.
- For part 2, subjects of 12 years to 17 years of age at the timing of the signature on the informed consent.
- For part 3, subjects of 2 years to 11 years of age at the timing of the signature on the informed consent.
- Good health and free of significant diseases or clinically significant abnormal findings on physical exam and laboratory evaluations.
- No history or presence of gastrointestinal, hepatic, or renal disease/disorder.
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- History of allergic disease confirmed by 2 or more episodes in past 5 years.
- Positive skin prick test to two or more common allergens.
- Subjects who are of childbearing potential must agree to remain abstinent from heterosexual activity or agree to use (or have their partner use) acceptable contraception to prevent pregnancy within projected duration of the trial.
Who cannot join
- Presence or history of any significant acute or chronic medical illness, except for allergic disease.
- BMI > 32 kg/m2 at the time of signing consent.
- Current or persistent moderate to sever asthma that requires use of control medication (Step 3 or above, according to Asthma Step Program).
- Presence of rhinitis secondary to causes other than allergy.
- History of anaphylaxis.
- Any known allergies to two or more of the following three antibiotics: Augmentin, tetracycline, or bacitracin.
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- Inability to be venipunctured and/or tolerate venous access (Parts 1 and 2 only).
- Consistent consumption of probiotics ≥ 2 days / week over multiple weeks within the 3 months prior to the study Baseline Visit.
- Regular use of any of the following medications:
- Intranasal or systemic corticosteroids (in 1 month prior to screening or during study)
- Leukotriene modifiers (in 1 month prior to screening or during study)
- Intranasal cromolyn (in 2 weeks prior to screening or during study)
- Intranasal or systemic decongestants (in 3 days prior to screening or during study)
- Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine (in 10 days prior to screening or during study)
- Intranasal antihistamines (in 3 days prior to screening or during study)
- Other systemic antihistamines (in 3 days prior to screening or during study)
- Allergies to excipients in the Investigational Product formulation.
- Allergy to soy in any form.
- Presently consuming alcohol more than 2 glasses per day or has history of alcohol dependence or alcohol abuse during the past one year prior to screening.
- Presently a smoker or ex-smoker with history of smoking (subject must abstain from smoking throughout the study).
- History or presence of significant recreational or illicit drug abuse in past 1 year.
- Participation in another clinical study within 30 days prior to screening.
- Use of any probiotic or prebiotic in the past 3 months prior to screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Bensch Clinical Research LLC
Stockton, California, 95207
Sandra Vallery, 209-951-6741, sandyval@aol.com
George W Bensch, MD
- Recruiting
Orange County Research Center
Tustin, California, 92780
Ashley Castro, 714-263-7328, ashley.castro@OCResearchCenter.com
Joel Neutel, MD
About this study
Official title: A Phase 1b, Multi-centered, Randomized, Double-blind, Placebo-controlled, Parallel Group, Three Sequential Part Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy
The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy.
Read the detailed description
This is a first-in-human trial of this live biotherapeutic product. The primary objective is to assess safety and tolerability in allergic subjects who are otherwise healthy, with twice daily dosing in descending age groups.
- Being tested
- STMC-103H, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STMC-103HBiological
Live bacterial product
PlaceboBiological
Inactive placebo substance
| Study group | Role | What they receive |
|---|---|---|
| STMC-103H | Experimental | Oral administration of STMC-103H twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups:
Part 1: 20 subjects 18-40 years of age Part 2: 20 subjects, 12-17 years of age Part 3: 20 subjects, 2-11 years of age Receives: Biological: STMC-103H |
| Placebo | Placebo comparator | Oral administration of placebo twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups:
Part 1: 20 subjects 18-40 years of age Part 2: 20 subjects, 12-17 years of age Part 3: 20 subjects, 2-11 years of age Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29.
All adverse events (AEs) recorded during the study through the date of randomization up to 28 days after the last dose of study drug will analyzed.
Treatment-emergent AEs (TEAEs), defined as any AE that starts or increases in severity after the first dose of STMC-103H or placebo, will be summarized. The total number of reported AEs will also be summarized.
Measured: From baseline to day 57
Incidence of abnormal laboratory test results from baseline to day 29
The change in laboratory results from baseline to day 29 in multi-sensitized (to two or more allergens) subjects who are otherwise healthy and who have completed BID dosing of STMC-103H or placebo for 28 days
Measured: From baseline to day 29
Change in blood pressure from baseline to day 57
Observed values of blood pressure obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit.
Measured: From baseline to day 57
Change in respiration rate from baseline to day 57
Observed values of respiration rate obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit.
Measured: From baseline to day 57
Change in heart rate from baseline to day 57
Observed values of heart rate obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit.
Measured: From baseline to day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start10 Oct 2018
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Immunoglobulin E-Mediated Allergic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Patients will be randomized into two arms in three sequential age-descending cohorts: Part 1: 18-40 years of age Part 2: 12-17 years of age Part 3: 2-11 years of age
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siolta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- Joel Neutel, MD, Principal investigator, Orange County Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819881
- Sponsor's protocol ID
- STMC-103H-101
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multi-centered, Randomized, Double-blind, Placebo-controlled, Parallel Group, Three Sequential Part Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy
- ClinicalTrials.gov ID
- NCT03819881
- Acronym / sponsor ID
- STMC-103H-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Siolta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy.
Detailed description
This is a first-in-human trial of this live biotherapeutic product. The primary objective is to assess safety and tolerability in allergic subjects who are otherwise healthy, with twice daily dosing in descending age groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into two arms in three sequential age-descending cohorts: Part 1: 18-40 years of age Part 2: 12-17 years of age Part 3: 2-11 years of age
| Arm | Type | Receives |
|---|---|---|
| STMC-103H | Experimental | Biological: STMC-103HOral administration of STMC-103H twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups: Part 1: 20 subjects 18-40 years of age Part 2: 20 subjects, 12-17 years of age Part 3: 20 subjects, 2-11 years of age |
| Placebo | Placebo comparator | Biological: PlaceboOral administration of placebo twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups: Part 1: 20 subjects 18-40 years of age Part 2: 20 subjects, 12-17 years of age Part 3: 20 subjects, 2-11 years of age |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Voluntary informed consent from subject or legally acceptable representative and/or child assent from the subject (as applicable).
- For part 1, subjects of 18 years to 40 years of age at the timing of the signature on the informed consent.
- For part 2, subjects of 12 years to 17 years of age at the timing of the signature on the informed consent.
- For part 3, subjects of 2 years to 11 years of age at the timing of the signature on the informed consent.
- Good health and free of significant diseases or clinically significant abnormal findings on physical exam and laboratory evaluations.
Key exclusion criteria (23 listed)
- Presence or history of any significant acute or chronic medical illness, except for allergic disease.
- BMI > 32 kg/m2 at the time of signing consent.
- Current or persistent moderate to sever asthma that requires use of control medication (Step 3 or above, according to Asthma Step Program).
- Presence of rhinitis secondary to causes other than allergy.
- History of anaphylaxis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STMC-103HLive bacterial product | Biological | STMC-103H |
| PlaceboInactive placebo substance | Biological | Placebo |
Primary outcome
Number of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29.
Time frame: From baseline to day 57
All adverse events (AEs) recorded during the study through the date of randomization up to 28 days after the last dose of study drug will analyzed. Treatment-emergent AEs (TEAEs), defined as any AE that starts or increases in severity after the first dose of STMC-103H or placebo, will be summarized. The total number of reported AEs will also be summarized.
Incidence of abnormal laboratory test results from baseline to day 29
Time frame: From baseline to day 29
The change in laboratory results from baseline to day 29 in multi-sensitized (to two or more allergens) subjects who are otherwise healthy and who have completed BID dosing of STMC-103H or placebo for 28 days
Change in blood pressure from baseline to day 57
Time frame: From baseline to day 57
Observed values of blood pressure obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit.
Change in respiration rate from baseline to day 57
Time frame: From baseline to day 57
Observed values of respiration rate obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit.
Change in heart rate from baseline to day 57
Time frame: From baseline to day 57
Observed values of heart rate obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Neutel, MD principal investigator
Orange County Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STMC-103H in people with Atopic Immunoglobulin E-Mediated Allergic Disorder, run by Siolta Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Chesnut (404-803-0358, echesnut@sioltatherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29. (time frame: From baseline to day 57). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.