Trial · NCT04988087
A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)
NCT04988087, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2024-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD). Trials, record NCT04988087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04988087
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)
- NCT number
- NCT04988087
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Sjogren Syndrome, Mixed Connective Tissue Disease
- Interventions
- MHV370, Placebo
- First posted
- 2021-08-03
- Last updated
- 2024-10-09
- Other registries' IDs
- eudract:2020-004937-19
- Results first posted
- 2024-07-08
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | SjS Participants: Change From Baseline in Eular Sjögren's Disease Activity Index (ESSDAI) After 24 Weeks of Treatment | Baseline, Week 24 | The ESSDAI is an established disease outcome measure for Sjögren's syndrome that classifies disease activity in 3-4 levels according to their severity (i.e., no, low, moderate, high), over each of 12 organ-specific domains. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The score range is 0 - 123, where a higher ESSDAI score indicates more severe symptoms. A negative change score from baseline indicates improvement. |
| Primary | MCTD Participants: Change From Baseline in Physician's Global Assessment Scale (PhGA) After 24 Weeks of Treatment | Baseline, Week 24 | The physician's global assessment scale is used for the Investigator to rate the disease activity of their patient using 100 mm visual analog scale (VAS) ranging from "no disease activity" (0) to "maximal disease activity" (100). A negative change score from baseline indicates improvement. Only participants with evaluable records are included. |
| Secondary | SjS and MCTD Participants: Maximum Observed Plasma Concentrations (Cmax) of MHV370 at Steady State | pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4 | Cmax is the maximum (peak) observed plasma concentration of MHV370 after single dose administration. Pharmacokinetic (PK) parameters were calculated based on MHV370 plasma concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1.0 ng/mL. Cmax was determined using non-compartmental methods. |
| Secondary | SjS and MCTD Participants: Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours (AUC0-6h) of MHV370 | pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4 | The AUC from time zero to the 6-hours post-dose sampling time. Pharmacokinetic (PK) parameters were calculated based on MHV370 plasma concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1.0 ng/mL. AUClast was determined using non-compartmental methods. |
| Secondary | SjS and MCTD Participants: Time to Reach Maximum Plasma Concentrations (Tmax) of MHV370 at Steady State | pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4 | Tmax is the time to reach maximum (peak) plasma concentration of MHV370 after single dose administration. Pharmacokinetic (PK) parameters were calculated based on MHV370 plasma concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1.0 ng/mL. Tmax was determined using non-compartmental methods. |
| Secondary | SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale | Baseline, Weeks 4, 8, 12, 20 and 24 | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F v4) is a short, 13-item patient-reported measure, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. 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). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52, where a higher FACIT-F score indicates more severe symptoms. A negative change score from baseline indicates improvement. |
| Secondary | SjS and MCTD Participants: Change From Baseline in Physician Global Assessment (PhGA) | Baseline, Weeks 4, 8, 12, 20 and 24 | The physician's global assessment scale is used for the Investigator to rate the disease activity of their patient using 100 mm visual analog scale (VAS) ranging from "no disease activity" (0) to "maximal disease activity" (100). A negative change score from baseline indicates improvement. |
| Secondary | SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) | Baseline, Weeks 4, 8, 12, 20 and 24 | The ESSDAI is an established disease outcome measure for Sjögren's syndrome that classifies disease activity in 3-4 levels according to their severity (i.e., no, low, moderate, high), over each of 12 organ-specific domains. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The score range is 0 - 123, where a higher ESSDAI score indicates more severe symptoms. A negative change score from baseline indicates improvement. |
| Secondary | SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI) | baseline, weeks 4, 8, 12, 20 and 24 | The ESSPRI is an established disease outcome measure for Sjögren's syndrome. The ESSPRI is a patient-reported, subjective symptom index which consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). The participant can assess severity of symptoms they experience on a single numerical scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable) for each of the three domains. The overall ESSPRI 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, where a higher ESSPRI score indicates more severe symptoms. A negative change score from baseline indicates improvement. |
| Secondary | SjS Participants: Change From Baseline to the Salivary Flow Rate | Baseline, Weeks 4, 12 and 24 | Unstimulated whole salivary fluid secretions were collected over 5 minutes from participants. All assessments were performed at a fixed time of the day to minimize fluctuations related to the circadian rhythm of salivary flow and composition. Participants were instructed not to eat, drink or smoke for 90 minutes before the assessment. The start time and end time of saliva collection were recorded to calculate the salivary flow rate per minute. Only participants with evaluable records are included. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | SjS Participants: Change From Baseline in Eular Sjögren's Disease Activity Index (ESSDAI) After 24 Weeks of Treatment | Baseline, Week 24 | The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. The data includes only participants who completed Week 24. Only participants with evaluable records are included. | Score on scale | MEAN |
| PRIMARY | MCTD Participants: Change From Baseline in Physician's Global Assessment Scale (PhGA) After 24 Weeks of Treatment | Baseline, Week 24 | The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. The data includes only participants who completed Week 24. Only participants with evaluable records are included. | Score on scale | MEDIAN |
| SECONDARY | SjS and MCTD Participants: Maximum Observed Plasma Concentrations (Cmax) of MHV370 at Steady State | pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4 | The pharmacokinetic (PK) analysis set included participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received MHV370 and with no protocol deviations with impact on PK data. Only participants with evaluable records are included. | ng/mL | MEAN |
| SECONDARY | SjS and MCTD Participants: Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours (AUC0-6h) of MHV370 | pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4 | The pharmacokinetic (PK) analysis set included participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received MHV370 and with no protocol deviations with impact on PK data. Only participants with evaluable records are included. | ng*h/mL | MEAN |
| SECONDARY | SjS and MCTD Participants: Time to Reach Maximum Plasma Concentrations (Tmax) of MHV370 at Steady State | pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4 | The pharmacokinetic (PK) analysis set included participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received MHV370 and with no protocol deviations with impact on PK data. Only participants with evaluable records are included. | hours | MEDIAN |
| SECONDARY | SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale | Baseline, Weeks 4, 8, 12, 20 and 24 | The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included. | Score on scale | MEAN |
| SECONDARY | SjS and MCTD Participants: Change From Baseline in Physician Global Assessment (PhGA) | Baseline, Weeks 4, 8, 12, 20 and 24 | The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Data from participants who have discontinued treatment early are regarded as missing after the treatment discontinuation. Only participants with evaluable records are included. | Score on scale | MEAN |
| SECONDARY | SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Disease Activity Index (ESSDAI) | Baseline, Weeks 4, 8, 12, 20 and 24 | The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Only participants with evaluable records are included. | Score on scale | MEAN |
| SECONDARY | SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI) | baseline, weeks 4, 8, 12, 20 and 24 | The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. Only participants with evaluable records are included. | Score on scale | MEAN |
| SECONDARY | SjS Participants: Change From Baseline to the Salivary Flow Rate | Baseline, Weeks 4, 12 and 24 | The pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD/efficacy data. | mL/min | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group107
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| SjS Participants: Change From Baseline in Eular Sjögren's Disease Activity Index (ESSDAI) After 24 Weeks of Treatment | Placebo - SjS | -4.39 | Standard Error 2.41 | Score on scale | |
| MCTD Participants: Change From Baseline in Physician's Global Assessment Scale (PhGA) After 24 Weeks of Treatment | MHV370 200mg - MCTD | -62.00 | Full Range -62.00 to -62.00 | Score on scale | |
| SjS and MCTD Participants: Maximum Observed Plasma Concentrations (Cmax) of MHV370 at Steady State | MHV370 200mg - SjS | 278 | Standard Deviation 85.7 | ng/mL | |
| SjS and MCTD Participants: Maximum Observed Plasma Concentrations (Cmax) of MHV370 at Steady State | MHV370 200mg - MCTD | 194 | ng/mL | ||
| SjS and MCTD Participants: Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours (AUC0-6h) of MHV370 | MHV370 200mg - SjS | 1060 | Standard Deviation 462 | ng*h/mL | |
| SjS and MCTD Participants: Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours (AUC0-6h) of MHV370 | MHV370 200mg - MCTD | 742 | ng*h/mL | ||
| SjS and MCTD Participants: Time to Reach Maximum Plasma Concentrations (Tmax) of MHV370 at Steady State | MHV370 200mg - SjS | 1.50 | Full Range 1.00 to 4.00 | hours | |
| SjS and MCTD Participants: Time to Reach Maximum Plasma Concentrations (Tmax) of MHV370 at Steady State | MHV370 200mg - MCTD | 2.00 | hours | ||
| SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale | MHV370 200mg - SjS | Week 4 | 0.13 | Standard Deviation 3.271 | Score on scale |
| SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale | Placebo - SjS | Week 4 | -1.58 | Standard Deviation 6.052 | Score on scale |
1 to 10 of 107Source ClinicalTrials.gov
See all 107 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MHV370 200mg - SjS | 12 | |
| Overall Study | STARTED | Placebo - SjS | 14 | |
| Overall Study | STARTED | MHV370 200mg - MCTD | 2 | |
| Overall Study | STARTED | Placebo - MCTD | 2 | |
| Overall Study | COMPLETED | MHV370 200mg - SjS | 0 | |
| Overall Study | COMPLETED | Placebo - SjS | 4 | |
| Overall Study | COMPLETED | MHV370 200mg - MCTD | 1 | |
| Overall Study | COMPLETED | Placebo - MCTD | 0 | |
| Overall Study | NOT COMPLETED | MHV370 200mg - SjS | 12 | |
| Overall Study | NOT COMPLETED | Placebo - SjS | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events415
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 | Anaemia | Blood and lymphatic system disorders | sjs_MHV | 0 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | sjs_Placebo | 1 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | MCTD_MHV | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | MCTD_Placebo | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 1 | 30 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | sjs_MHV | 0 | 12 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | sjs_Placebo | 1 | 14 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MCTD_MHV | 0 | 2 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MCTD_Placebo | 0 | 2 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Total | 1 | 30 |
1 to 10 of 415Source ClinicalTrials.gov
See all 415 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | sjs_MHV | 0 | 12 |
| Total, all-cause mortality | sjs_Placebo | 0 | 14 |
| Total, all-cause mortality | MCTD_MHV | 0 | 2 |
| Total, all-cause mortality | MCTD_Placebo | 0 | 2 |
| Total, all-cause mortality | Total | 0 | 30 |
| Total, other adverse events | sjs_MHV | 12 | 12 |
| Total, other adverse events | sjs_Placebo | 12 | 14 |
| Total, other adverse events | MCTD_MHV | 1 | 2 |
| Total, other adverse events | MCTD_Placebo | 2 | 2 |
| Total, other adverse events | Total | 27 | 30 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT04988087/results?page=2