Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT07143669
Eligibility Criteria:
Key Inclusion Criteria:
* Cohort 1 participants must meet inclusion criteria for either SMAC-A or SMAC-B:
1\. SMAC-A
* Documented anaphylaxis due to Hymenoptera venom with cardiovascular symptoms or
* Documented anaphylaxis without known trigger(s) or allergen(s) warranting hospitalization, emergency room visit, and/or epinephrine with cardiovascular symptoms 2. SMAC-B
* Episodic or recurrent signs and symptoms consistent with mast cell activation without known triggers or allergens in at least 2 of the following organ systems: skin, respiratory/naso-ocular, gastrointestinal tract, or cardiovascular.
* Any clinical response on one or more optimally dosed therapies intended to mitigate mast cell mediators, as determined by the Investigator.
* Cohort 2 participants must have confirmed, known diagnosis of 1 of the following criteria:
1. Either hypermobile Ehlers-Danlos syndrome or documented history of hypermobility spectrum disorder.
2. Postural orthostatic tachycardia syndrome with one or more systemic symptoms.
3. Early onset (≤50 years old) osteoporosis or osteopenia.
* Cohort 3 participants must have documented diagnosis of 1 of the following, according to World Health Organization 5th edition criteria: chronic myelomonocytic leukemia or myelodysplastic syndrome/myeloproliferative neoplasm not otherwise specified.
Key Exclusion Criteria:
* Participants previously diagnosed with any of the following:
1. Monoclonal mast cell activation syndrome with a known KIT mutation
2. Cutaneous mastocytosis only (that is, no documentation of systemic mast cell disease via bone marrow biopsy)
3. Any subtype of systemic mastocytosis
4. Mast cell sarcoma
* Cohort 2 only: Osteopenia or osteoporosis attributed to known genetic, endocrine, nutritional, or other medical conditions.
Note: Additional protocol-defined criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07143669
Study Brief:
Protocol Section:
NCT07143669