Randomized, Double-blind, Placebo-controlled, Crossover Design, Efficacy and SafetyStudy with PA101 in Patients with Indolent Systemic Mastocytosis

Patara Pharma, LLC0 sites36 target enrollmentDecember 22, 2014

Overview

No summary available.

Registry

who.int

Start Date

December 22, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male or female patients 18\-75 years of age, inclusive
•2\. Diagnosed with indolent systemic mastocytosis (ISM) according to the WHO criteria and the consensus proposal (2001\)
•3\. Experiencing at least one qualifying symptom in at least two organ systems during the 3 months preceding the Screening Visit, despite the use of H1 and H2 antihistamines and other antimediator therapy
•4\. Experiencing symptoms with a severity score of at least 4 for at least 7 out of 14 days during the Run\-in Period with at least one qualifying symptom each from at least two organ systems, despite the use of H1 and H2 antihistamines and other anti\-mediator therapy
•5\. Willing and able to use an eDiary device daily for the duration of the study
•6\. Completed at least 5 eDiary reports during each of two consecutive weeks of the Run\-in Period
•7\. Patients must digitally accept the licensing agreement in the eDiary software
•8\. Willingness and ability to provide written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\. Advanced systemic mastocytosis (i.e., aggressive systemic mastocytosis \[ASM], mast cell leukemia \[MCL], or systemic mastocytosis with an associated clonal hematologic non\-mast cell lineage disease \[SM\-AHNMD] )
•2\. Current or recent history of clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that could put the patient at risk or compromise the quality of the study data as determined by the Investigator
•3\. Use of oral cromolyn sodium within 6 weeks of the Screening Visit
•4\. History of systemic corticosteroid, immunosuppressive, or anti\-IgE monoclonal antibody therapy (e.g., omalizumab) within 6 months of the Screening Visit
•5\. History of anaphylaxis requiring systemic treatment (i.e., corticosteroid or epinephrine) within 12 months of the Screening Visit
•6\. An upper or lower respiratory tract infection within 4 weeks of the Screening Visit
•7\. History of malignancy within the last 5 years, except basal cell carcinoma or cervix carcinoma in situ
•8\. Major surgery within 6 months of the Screening Visit
•9\. History of excessive use or abuse of alcohol (i.e., more than 3 units per day, or more than 21 units per week) within 12 months of the Screening Visit
•10\. History of abusing legal drugs or use of illegal drugs or substances within 12 months of the Screening Visit