Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173

A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004616-12-DE

Enrollment

Registered

2016-03-17

Start date

2016-05-20

Completion date

Unknown

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren's syndrome MedDRA version: 19.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Code: CDZ173 Pharmaceutical Form: Capsule, hard INN or Proposed INN: leniolisib Other descriptive name: CDZ173 Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Diagnosis of primary Sjögren’s syndrome • ESSDAI score = 6 at screening visit; Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Secondary Sjögren’s syndrome Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To assess the safety and tolerability of CDZ173 in patients with primary Sjögren’s syndrome. • To compare the effect of CDZ173 versus placebo on the patient-reported outcomes of primary Sjögren’s syndrome patients after 12 weeks of treatment (study week 13). ;Secondary Objective: • To assess the pharmacokinetics of CDZ173 in primary Sjögren’s syndrome patients • To evaluate the effect of CDZ173 versus placebo on clinical disease outcomes in primary Sjögren’s syndrome patients after 12 weeks of treatment • To evaluate the changes in the physician global assessment of the patient’s overall disease activity after 12 weeks of treatment. • To evaluate the changes in the patients global assessment of their disease activity after 12 weeks of treatment;Primary end point(s): EULAR Sjögren’s Syndrome Patient Reported Intensity (ESSPRI) change from baseline;Timepoint(s) of evaluation of this end point: Primary endpoint evaluation after 12 week treatment.	—

Measure

Time frame

Main Objective: • To assess the safety and tolerability of CDZ173 in patients with primary Sjögren’s syndrome. • To compare the effect of CDZ173 versus placebo on the patient-reported outcomes of primary Sjögren’s syndrome patients after 12 weeks of treatment (study week 13). ;Secondary Objective: • To assess the pharmacokinetics of CDZ173 in primary Sjögren’s syndrome patients • To evaluate the effect of CDZ173 versus placebo on clinical disease outcomes in primary Sjögren’s syndrome patients after 12 weeks of treatment • To evaluate the changes in the physician global assessment of the patient’s overall disease activity after 12 weeks of treatment. • To evaluate the changes in the patients global assessment of their disease activity after 12 weeks of treatment;Primary end point(s): EULAR Sjögren’s Syndrome Patient Reported Intensity (ESSPRI) change from baseline;Timepoint(s) of evaluation of this end point: Primary endpoint evaluation after 12 week treatment.

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Secondary

Measure	Time frame
Secondary end point(s): ? EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) change from baseline ? Physician global assessment of the patient's overall disease activity (VAS) change from baseline ? Patient’s global assessment of their disease activity (VAS) change from baseline;Timepoint(s) of evaluation of this end point: Secondary endpoint evaluation after 12 week treatment.	—

Countries

Germany, Hungary, Poland

Contacts

Public ContactMedizinischer Infoservice (MCC)

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026