Trial · NCT05350072
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in EULAR Sjogren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo | 48 weeks | Efficacy (Plan A: US and US reference countries and Plan B: EU, China, other non-US Regions and EU reference countries) Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status. |
| Secondary | Achieving ESSDAI response at Week 48 | 48 weeks | Efficacy (Plan A and B) Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status. |
| Secondary | Achieving ESSDAI score <5 at Week 48 | 48 weeks | Efficacy (Plan A and B) Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status. |
| Secondary | Achieving ESSDAI response at Week 24 | 24 weeks | Efficacy (Plan A and B) Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status. |
| Secondary | Achieving SSSD response at Week 48 | 48 weeks | Efficacy (Plan B) The Sjogrens Syndrome Symptom Diary (SSSD) is questionnaire consists of five (six for females) questions about symptoms of Sjögren's syndrome, each question given a score of 0-10 (0=no symptoms, 10=worst possible symptoms) where patient choose the one response that best describes how severe the symptom was at its worst in the PAST 24 HOURS. It includes six symptom items (eye dryness, mouth dryness, skin dryness, physical fatigue, muscle and/or joint pain, genital dryness), and applies a recall period of 24 hrs. The aim of the SSSD is to establish patient reported endpoints for the treatment of Sjogrens syndrome. Participants will complete the diary daily for 7 days prior to the scheduled dosing. |
| Secondary | Change from baseline in stimulated whole salivary flow rate at Week 48 | 48 weeks | Efficacy (Plan A and B) |
| Secondary | Change from baseline in Physician's Global Assessment (PhGA) of disease activity at Week 48 | 48 weeks | Efficacy (Plan A and B) |
| Secondary | Change from baseline in Patient's Global Assessment (PaGA) of disease activity at Week 48 | 48 weeks | Efficacy (Plan A and B) |
| Secondary | Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48 | 48 weeks | Efficacy (Plan A and B) |
| Secondary | Achieving EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) response at Week 48 | 48 weeks | Efficacy (Plan B) |
| Other | Incidence of Treatment Emergent Adverse Event (TEAEs)/Serious Adverse Events (SAEs) upto the end of the study | through study completion upto 2 years | Safety (Plan A and B) |
| Other | Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay) up to end of study | through study completion up to 2 years | Immunogenicity (Plan A and B) |
| Other | Ianalumab concentration in serum during the treatment (example Ctrough) and follow-up (up to end of study) | through study completion up to 2 years | Pharmacokinetics (Plan A and B) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT05350072/registered