← Back to Search

PI3Kδ inhibitor

CDZ173 for Activated PI3Kdelta Syndrome

Phase 2 & 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have participated in the study CCDZ173X2201 or were treated previously with PI3Kδ inhibitors other than CDZ173

Documented APDS/PASLI-associated genetic PI3K delta mutation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

Study Summary

This trial will study the long-term effects of CDZ173, a drug that inhibits a protein called PI3Kδ, in patients who have a genetic mutation that activates PI3Kδ.

Who is the study for?

This trial is for patients with APDS/PASLI, a genetic condition causing enlarged lymph nodes and immune system issues. Participants must have been in the CCDZ173X2201 study or treated with other PI3Kδ inhibitors, understand the study requirements, and provide informed consent.Check my eligibility

What is being tested?

The trial tests long-term use of CDZ173, a drug targeting a specific part of cells (PI3Kδ) that's overactive in APDS/PASLI. It's an open-label study to assess safety, tolerability, effectiveness, and how the body processes the drug over time.See study design

What are the potential side effects?

As CDZ173 targets immune cell function, potential side effects may include increased risk of infections, possible allergic reactions to the medication itself or its components. Specific side effect details are not provided but will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been part of the CCDZ173X2201 study or treated with PI3Kδ inhibitors.

Select...

My condition is linked to a specific genetic mutation in PI3K delta.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the long term safety and tolerability of CDZ173 in patients with APDS/PASLI

Secondary outcome measures

To characterize the pharmacokinetics (trough concentration) of CDZ173 in patients with APDS/PASLI

To evaluate the long term efficacy of CDZ173 by means of biomarkers reflecting the efficacy of CDZ173 to reduce systemic inflammatory components of the disease in patients with APDS/PASLI

To evaluate the long term efficacy of CDZ173 to modify health-related quality of life in patients with APDS/PASLI

+1 more

Side effects data

From 2021 Phase 2 & 3 trial • 37 Patients • NCT02435173

17%

Cough

17%

Amylase increased

17%

Blood creatine phosphokinase increased

17%

Lipase increased

100%

80%

60%

40%

20%

Study treatment Arm

Part I: CDZ173 10 mg

Part I: CDZ173 30 mg

Part I: CDZ173 70 mg

Part II: Placebo

Part II: CDZ173 70 mg

Part I: Total

Trial Design

1Treatment groups

Experimental Treatment

Group I: CDZ173Experimental Treatment1 Intervention

140mg/day

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CDZ173

2015

Completed Phase 3

~70

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,313 Total Patients Enrolled

Pharming Technologies B.V.Lead Sponsor

20 Previous Clinical Trials

1,351 Total Patients Enrolled

Media Library

CDZ173 (PI3Kδ inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02859727 — Phase 2 & 3

Activated PI3Kdelta Syndrome or PASLI Disease Research Study Groups: CDZ173

Activated PI3Kdelta Syndrome or PASLI Disease Clinical Trial 2023: CDZ173 Highlights & Side Effects. Trial Name: NCT02859727 — Phase 2 & 3

CDZ173 (PI3Kδ inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02859727 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this test allow participants who are senior citizens?

"The youngest patients that can be enrolled in this study are 12 years old while the cut-off age is 75."

Answered by AI

Are new participants still being accepted into this research project?

"This specific trial, which was first announced on September 8th, 2016 is not currently looking for participants according to the listing on clinicaltrials.gov. The 1463 other trials might have more luck in finding patients right now."

Answered by AI

Could I take part in this research if I qualify?

"The ideal candidate for this study is somebody between the ages of 12 and 75 who has been diagnosed with a syndrome. In addition to this, potential participants must be able to meet the following criteria: They or their legal guardian (in the case of those under 18) must be able to communicate well with the researcher conducting the study, understand what is required of them, and agree to participate via written consent prior to any assessments being performed. Furthermore, patients must have either participated in the CCDZ173X2201 study previously or received treatment from another PI3Kδ inhibitor outside of CDZ173. Lastly, investigators leading the study"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLI

2016. "Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02859727.