STMC-103H for Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Children's Hospital at Westmead, Westmead, Australia
Dermatitis+5 More
STMC-103H - Biological
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can prevent allergic disease in children.

See full description

Eligible Conditions

  • Dermatitis
  • Dermatitis, Dermatitis Atopic
  • Type 1 Hypersensitivity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Dermatitis

Study Objectives

This trial is evaluating whether STMC-103H will improve 3 primary outcomes, 12 secondary outcomes, and 1 other outcome in patients with Dermatitis. Measurement will happen over the course of Through 56 days of study.

At day 336
Part B Key Exploratory Endpoint - Mean fecal concentration of 12,13-diHOME
Part B Secondary Efficacy Endpoint - Peripheral Eosinophil Counts
Day 168
Part B Secondary Efficacy Endpoint - physician-diagnosed atopic dermatitis
Day 168
Part B - Secondary Efficacy Endpoint - atopic disease assessments
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Investigator Global Assessment x Body Surface Area (IGAxBSA) assessment
Part B Secondary Efficacy Endpoint - severity of atopic dermatitis by Severity Scoring Of Atopic Dermatitis (SCORAD) assessment
Day 168
Part B Secondary Efficacy Endpoint - Total Serum IgE
Part B Secondary Efficacy Endpoint - incidence of food allergy, allergic rhinitis/conjunctivitis, urticaria, and wheezing illness/asthma
Part B Secondary Efficacy Endpoint - incidence of sensitization to food and aeroallergen
Day 672
Part B Secondary Efficacy Endpoint - Severity of Wheezing Illness/Asthma
Day 336
Part B: Primary Efficacy Endpoint: Incidence of physician-diagnosed atopic dermatitis at 336 days
Day 56
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
Day 672
Part B Secondary Efficacy Endpoint - Time to atopic dermatitis diagnosis
Part B Secondary Efficacy Endpoint - Time to first wheezing episode
Part B Secondary Efficacy Endpoint - use of concomitant medications for allergic symptoms or diagnosis
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.

Trial Safety

Safety Progress

1 of 3

Other trials for Dermatitis

Trial Design

6 Treatment Groups

STMC-102H Part A2
1 of 6
STMC-103H Part A1
1 of 6
STMC-103H Part B
1 of 6
Placebo Part A1
1 of 6
Placebo Part B
1 of 6
Placebo Part A2
1 of 6
Experimental Treatment
Non-Treatment Group

This trial requires 264 total participants across 6 different treatment groups

This trial involves 6 different treatments. STMC-103H is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

STMC-102H Part A2
Biological
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
STMC-103H Part A1
Biological
Once daily dosing with one capsule of STMC-103H mixed with milk, formula, or a milk product for 28 days
STMC-103H Part B
Biological
Once daily dosing with one capsule of STMC-103H mixed with breastmilk, formula or a milk product for 28 days
Placebo Part A1
Biological
Once daily dosing with one capsule of placebo mixed with milk, formula, or a milk product for 28 days
Placebo Part B
Biological
Once daily dosing with one capsule of placebo mixed with breastmilk, formula or a milk product for 28 days
Placebo Part A2
Biological
Once daily dosing with one capsule of placebo mixed with milk, formula or a milk product for 28 days

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at days 168, 336 and 672
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at days 168, 336 and 672 for reporting.

Closest Location

UCSF Benioff Children's Hospital - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All Parts (A1, A2, B)
Subject's parent(s)/legal representative(s) providing consent must be 18 years or older
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
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
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
5 (A1). Subject is between 1 year and < 6 years old at the time of enrollment
Part A2 Only
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

Patient Q&A Section

What are the signs of hypersensitivity?

"Symptoms of hypersensitivity include a feeling of coldness, headache, and muscle weakness. Other, less common symptoms include hives and swelling of the face, lips, tongue, throat, ears, or throat and neck. These symptoms usually precede a rash with itching sensations.\n" - Anonymous Online Contributor

Unverified Answer

Can hypersensitivity be cured?

"The treatment of hypersensitivity is less radical, and thus less successful. It may be that we are still studying the right method and administering the method in a more effective way. With respect to the treatment of hypersensitivity, the current study suggests, first, that clinicians can manage hypersensitivity better if they understand the underlying mechanisms, are aware of their own biases, and choose to use the most appropriate method for the given situation." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hypersensitivity?

"We recommend to try the drugs recommended by the European College of Allergy and Immunology instead of the drugs recommended by the American College of Allergy, Asthma, and Immunology. It is essential to be aware about the dangers of all these drugs during the application. And when considering the patients it is important to understand the possible combinations of the drugs which could result in new side effects. Other drugs like NSAIDs and statins should be prescribed cautiously in the elderly and women taking oral contraception." - Anonymous Online Contributor

Unverified Answer

How many people get hypersensitivity a year in the United States?

"A few patients in every hundred get HSP annually. The great majority, however, get the disease infrequently. The frequency of occurrence of HSP is thought to depend on both the frequency of the antigen and the amount of antigen in the environment." - Anonymous Online Contributor

Unverified Answer

What is hypersensitivity?

"The study showed that patients with SJS and AGEP are prone to developing hypersensitivity hypersensitivity. They are also at risk for developing adverse effects related to medications related to allergic reaction such as ACE inhibitors, angiotensin receptor blockers, nonsteroidal anti-inflammatory drugs, corticosteroids, and immunosuppressants. Physicians and patients should be informed of the potential for allergies and hypersensitive reactions. Further research regarding the relationship between allergy and hypersensitivity needs to be investigated." - Anonymous Online Contributor

Unverified Answer

What causes hypersensitivity?

"Immune hypersensitivity reactions are believed to be one cause of allergic bronchopulmonary aspergillosis and hypersensitivity pneumonitis. Allergy to mold, insects and some environmental irritants causes allergic bronchopulmonary aspergillosis. In contrast, inhalant hypersensitivity to metals, silicates, food additives and pesticides leads to hypersensitivity pneumonitis. The hypersensitive reaction in idiopathic pulmonary fibrosis most commonly occurs to inhaled silicates. The hypersensitive reaction also occurs in the setting of systemic immunosuppression, such as in recipients of cytotoxic drugs." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving stmc-103h?

"The present results should be useful to all investigators conducting clinical trials of the stmc-103h molecule, as it may help determine the utility of such stmc-103h molecule in treatment of various disease indications in comparison with currently used anticancer drugs, which are mainly based on cytotoxic effects or immunosuppressive effects." - Anonymous Online Contributor

Unverified Answer

Does stmc-103h improve quality of life for those with hypersensitivity?

"Stmc-103h (5 x 1 g oral, once daily for 7 days) improved QoL in a cohort of patients with hypersensitivity to both steroids and antibiotics. In a phase 3 multicenter, randomized trial, in which patients will be randomized to treatment or placebo, Stmc-103h is being evaluated as a treatment for patients with systemic hypersensitivity reactions to both steroids and antibiotics." - Anonymous Online Contributor

Unverified Answer

How does stmc-103h work?

"The data indicate that stmc-103h exerts its therapeutic effects through modulation of innate and adaptive immune responses that are mediated chiefly through the suppression of pro-inflammatory IL-12p70 and the consequential reduction in the activation of IFN-γ-producing T-cells." - Anonymous Online Contributor

Unverified Answer

How serious can hypersensitivity be?

"Most hypersensitizants tested are extremely dangerous, producing death by acute asthma or other allergic reactions in severe cases. For those with moderate reactions, life-threatening asthma could also occur." - Anonymous Online Contributor

Unverified Answer

Is stmc-103h typically used in combination with any other treatments?

"In addition, the stmc-103h has been used as the sole treatment in combination with other conventional treatments (2/4 trials) and in combination with interferon (1 trial). Due to the preliminary nature of these studies, conclusions on the use of stmc-103h alone or in combination with other treatments cannot be made." - Anonymous Online Contributor

Unverified Answer

What is stmc-103h?

"Stmc-103h has a broad in vitro antiinflammatory activity that has demonstrated efficacy in phase II clinical trials when given subcutaneously or intravenously to patients with rheumatoid arthritis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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