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Study of Efficacy of CDZ173 in Patients With APDS/PASLI

NCT02435173 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-08-10

Study results available
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Summary

This study was designed to explore CDZ173, a selective PI3Kδ inhibitor, in patients with genetically activated PI3Kδ, i.e., patients with Activated phosphoinositide 3-kinase delta syndrome/ p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency (APDS/PASLI).

The study consisted of two parts: Part I was the open label part designed to establish the safety and pharmacokinetics of CDZ173 in the target population, as well as to select the optimal dose to be tested in Part II. Part II was designed to assess efficacy and safety of CDZ173 in the target population.

Conditions

  • Common Variable Immunodeficiency (CVID), APDS / PASLI

Interventions

DRUG

CDZ173

CDZ173 10 and 70 mg capsules for oral administration.

OTHER

Placebo

Placebo capsules for oral administration

Sponsors & Collaborators

Principal Investigators

  • Koneti V Rao, MD · National Institutes of Health (NIH)

  • Virgil Dalm, MD · Erasmus Medical Center

  • Anna Šedivá, MD · Motol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-24
Primary Completion
2021-08-16
Completion
2021-08-16
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Czechia
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT02435173 on ClinicalTrials.gov