NCT02775916

Brief Summary

This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173 in patients with primary Sjögren's syndrome.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 18, 2019

Completed
Last Updated

January 5, 2021

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

May 16, 2016

Results QC Date

May 14, 2018

Last Update Submit

December 9, 2020

Conditions

Primary Sjögren's Syndrome

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85

    Safety and tolerability of CDZ173 in patients with primary Sjögren's syndrome up to End of Treatment Day 85

    up to Day 85

  • Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85

    The ESSPRI is an established disease outcome measure for Sjögren's syndrome. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10.

    Baseline and 12 weeks (Day 85)

Secondary Outcomes (5)

  • Change From Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) After 12 Weeks of Treatment Day 85

    Baseline and 12 weeks (Day 85)

  • Change From Baseline in the Short Form (36) Health Survey (SF-36) After 12 Weeks of Treatment Day 85

    Baseline and 12 weeks (Day 85)

  • Change in Baseline in Multidimensional Fatigue Inventory (MFI) After 12 Weeks of Treatment (Day 85)

    Baseline and 12 weeks (Day 85)

  • Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (Physician VAS) After 12 Weeks of Treatment Day 85

    Baseline and 12 weeks (Day 85)

  • Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) After 12 Weeks of Treatment Day 85

    Baseline and 12 weeks

Study Arms (2)

CDZ173

EXPERIMENTAL

Capsule

Drug: CDZ173

Placebo

PLACEBO COMPARATOR

Capsule matching Placebo

Drug: Placebo

Interventions

CDZ173DRUG
CDZ173
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of primary Sjögren's syndrome (pSS)
  • ESSDAI score ≥ 6 at screening visit

You may not qualify if:

  • Secondary Sjögren's syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Debrecen, 4032, Hungary

Location

Related Links

MeSH Terms

Interventions

leniolisib

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
8627788300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 18, 2016

Study Start

June 1, 2016

Primary Completion

May 17, 2017

Study Completion

May 17, 2017

Last Updated

January 5, 2021

Results First Posted

October 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Locations

HU(1)DE(1)