MedTrace Logo

Treatment of Indolent Systemic Mastocytosis With PA101

NCT02478957 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-09-29

No results posted yet for this study

Summary

This is a randomized, placebo- and active-controlled, 2-period crossover, 2 cohort study in adult patients with indolent systemic mastocytosis (ISM).

The purpose of the study is to determine the efficacy and safety profile of PA101 delivered via eFlow high efficiency nebulizer in patients with ISM who are symptomatic despite using standard treatments.

Conditions

Interventions

DRUG

PA101

40 mg PA101 administered via inhalation three times daily for 6 weeks

DRUG

Placebo

matching placebo administered via inhalation three times daily for 6 weeks

Sponsors & Collaborators

  • Patara Pharma

    lead INDUSTRY

Principal Investigators

  • Frank Siebenhaar, MD · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-03-31
Completion
2016-06-30

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02478957 on ClinicalTrials.gov