Trial · NCT05349214
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plan A and B - Change from baseline in ESSDAI score at Week 48 | 48 weeks | * Plan A - United States of America and US reference countries * 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 | Change from baseline in SSSD score at Week 48 | 48 weeks | Efficacy (Plan A and 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 | Percentage of participants 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 | Percentage of participants 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 | Percentage of participants achieving SSSD response at Week 48** | 48 weeks | Efficacy (Plan A and 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) Both the amount and composition of saliva has been shown to reflect the glandular damage caused by the disease process of Sjögren's (Pijpe et al 2007). Unstimulated and stimulated salivary secretions are collected over 5 minutes. As much as possible the assessments are to be performed at a fixed time of the day to minimize fluctuations related to the circadian rhythm of salivary flow and composition (Dawes 1972). |
| Secondary | Change from baseline in PhGA at Week 48 | 48 weeks | Efficacy (Plan A and B) Physician global assessment of disease activity is made with relation to Sjögren's syndrome. Physician's global assessment (PhGA) of disease activity for Sjögren's syndrome is performed using 3 separate scales: * Visual Analog Scale (VAS) - an unnumbered 100 mm long horizontal line ranging from "no disease activity' to "maximal disease activity". The assessment of patient's condition on the day is made by placing a vertical mark across the line. * Numerical Rating Scale (NRS) - a segmented numeric version of the VAS. A respondent needs to select a whole number (0-10 integers), with 0 being "no disease activity" and 10 being "maximal disease activity". * 4-point Likert scale - The level of disease activity is assessed on a scale from "inactive" to "high activity". |
| Secondary | Change from baseline in PaGA at Week 48 | 48 weeks | Efficacy (Plan A and B) Patient's global assessment (PaGA) of disease activity for Sjögren's syndrome is performed using 3 separate scales: * Visual Analog Scale (VAS) - an unnumbered 100 mm long horizontal line ranging from "very good' to "very poor". The assessment is made by placing a vertical mark across the line. * Numerical Rating Scale - a segmented numeric version of the VAS. A respondent needs to select a whole number (0-10 integers), with 0 being "very poor" and 10 being "very good". * 4-point Likert scale - The level of symptom severity is assessed on a scale from "none to severe". |
| Secondary | Change from baseline in FACIT-F score at Week 48 | 48 weeks | Efficacy (Plan A and B) The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F version 4) is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the past week (Webster et al 2003). The level of fatigue is measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). |
| Secondary | Change from baseline in ESSPRI score at Week 48 | 48 weeks | Efficacy (Plan B) ESSPRI is an established disease outcome measure for Sjögren's (Seror et al 2011, Seror et al 2015). It consists of three domains of dryness, pain and fatigue. The subject assesses severity of symptoms they experience on a single 0-10 numerical scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. ESSPRI will be applied to the study patients at during runin period, at baseline and during study treatment. |
| Secondary | Percentage of participants achieving ESSPRI response at Week 48** | 48 Weeks | Efficacy (Plan B) ESSPRI is an established disease outcome measure for Sjögren's (Seror et al 2011, Seror et al 2015). It consists of three domains of dryness, pain and fatigue. The subject assesses severity of symptoms they experience on a single 0-10 numerical scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. ESSPRI will be applied to the study patients at during run-in period, at baseline and during study treatment. |
| Other | Incidence of Treatment-emergent AEs (TEAEs) /SAEs (Serious Adverse Event) upto the end of the study | Through study completion up to two years | Safety(Plan A and B) |
| Other | Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay to end of study | through study completion up to 2 years | Immunogenicity (Plan A and B) |
| Other | Ianalumab concentration in serum during the treatment and follow-up (up to the end of study) | throughout 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.
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