Trial · NCT02775916
Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome
NCT02775916, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-10-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome. Trials, record NCT02775916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02775916
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome
- NCT number
- NCT02775916
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Primary Sjögren's Syndrome
- Interventions
- CDZ173, Placebo
- First posted
- 2016-05-18
- Last updated
- 2021-01-05
- Other registries' IDs
- eudract:2014-004616-12
- Results first posted
- 2019-10-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 | up to Day 85 | Safety and tolerability of CDZ173 in patients with primary Sjögren's syndrome up to End of Treatment Day 85 |
| Primary | Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85 | Baseline and 12 weeks (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. |
| Secondary | 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) | The ESSDAI is an established disease outcome measure for Sjögren's syndrome. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. A reduction from baseline (i.e., a negative change from baseline) in the ESSDAI score is indicative of improvement in a patient.). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). |
| Secondary | 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) | The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden. |
| Secondary | Change in Baseline in Multidimensional Fatigue Inventory (MFI) After 12 Weeks of Treatment (Day 85) | Baseline and 12 weeks (Day 85) | The Multidimensional Fatigue Inventory (MFI) is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a possible range from 4-20. The reported total score has a range from 20-100. The reported total score has a range from 20-100, higher scores are associated with greater fatigue. |
| Secondary | 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) | A reduction from baseline (i.e., a negative change from baseline) in physician global VAS assessment score indicates improvement in patients. The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm). |
| Secondary | Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) After 12 Weeks of Treatment Day 85 | Baseline and 12 weeks | A reduction from baseline (or, a negative change from baseline) in patient global VAS assessment score indicates improvement in patients. The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 | up to Day 85 | Safety Analysis Set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the safety analysis set | count of participants | NUMBER |
| PRIMARY | Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85 | Baseline and 12 weeks (Day 85) | PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set | total score on scale | MEAN |
| SECONDARY | 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) | PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set | total score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set | total score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Baseline in Multidimensional Fatigue Inventory (MFI) After 12 Weeks of Treatment (Day 85) | Baseline and 12 weeks (Day 85) | PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set | total score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set | total score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) After 12 Weeks of Treatment Day 85 | Baseline and 12 weeks | PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set | total score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 | CDZ173 | Participants with at least one AE | 20 | count of participants | |
| Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 | Placebo | Participants with at least one AE | 8 | count of participants | |
| Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 | CDZ173 | Participants with at least one SAE | 1 | count of participants | |
| Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 | Placebo | Participants with at least one SAE | 0 | count of participants | |
| Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 | CDZ173 | Death | 0 | count of participants | |
| Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 | Placebo | Death | 0 | count of participants | |
| Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85 | CDZ173 | -1.778 | Standard Deviation 2.4509 | total score on scale | |
| Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85 | Placebo | -0.741 | Standard Deviation 1.3517 | total score on scale | |
| Change From Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) After 12 Weeks of Treatment Day 85 | CDZ173 | -2.82 | Standard Error 1.165 | total score on scale | |
| Change From Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) After 12 Weeks of Treatment Day 85 | Placebo | -3.34 | Standard Error 1.168 | total score on scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CDZ173 | 20 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | COMPLETED | CDZ173 | 17 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | CDZ173 | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry Eye | Eye disorders | CDZ173 | 1 | 20 | |
| other | Dry Eye | Eye disorders | Placebo | 1 | 10 | |
| other | Abdominal Pain | Gastrointestinal disorders | CDZ173 | 2 | 20 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 10 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | CDZ173 | 1 | 20 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Placebo | 1 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | CDZ173 | 5 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 10 | |
| other | Flatulence | Gastrointestinal disorders | CDZ173 | 1 | 20 | |
| other | Flatulence | Gastrointestinal disorders | Placebo | 3 | 10 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CDZ173 | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, other adverse events | CDZ173 | 19 | 20 |
| Total, other adverse events | Placebo | 8 | 10 |
| Total, serious adverse events | CDZ173 | 1 | 20 |
| Total, serious adverse events | Placebo | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CDZ173 vs Placebo: deaths from any cause | Trial comparisons |
| CDZ173 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02775916
GET https://conductscience.org/api/trials/v1/NCT02775916/events?page=2