A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)
TerminatedPhase 2Results postedLast updated 9 October 2024
What this trial tests
Phase 2 trial testing MHV370 in Sjogren Syndrome in 30 participants. Terminated before completion.
Adults 18 to 75, any sex, with Sjogren Syndrome or Mixed Connective Tissue Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
SjS Participants: Change From Baseline in Eular Sjögren's Disease Activity Index (ESSDAI) After 24 Weeks of TreatmentPrimary· 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.
Group
Value
95% CI
Placebo - SjS
-4.39
± 2.41
MCTD Participants: Change From Baseline in Physician's Global Assessment Scale (PhGA) After 24 Weeks of TreatmentPrimary· 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.
Group
Value
95% CI
MHV370 200mg - MCTD
-62.00
-62.00 – -62.00
SjS and MCTD Participants: Maximum Observed Plasma Concentrations (Cmax) of MHV370 at Steady StateSecondary· 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.
Group
Value
95% CI
MHV370 200mg - SjS
278
± 85.7
MHV370 200mg - MCTD
194
SjS and MCTD Participants: Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours (AUC0-6h) of MHV370Secondary· 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.
Group
Value
95% CI
MHV370 200mg - SjS
1060
± 462
MHV370 200mg - MCTD
742
SjS and MCTD Participants: Time to Reach Maximum Plasma Concentrations (Tmax) of MHV370 at Steady StateSecondary· 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.
Group
Value
95% CI
MHV370 200mg - SjS
1.50
1.00 – 4.00
MHV370 200mg - MCTD
2.00
SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) ScaleSecondary· 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 indi
Week 4
Group
Value
95% CI
MHV370 200mg - SjS
0.13
± 3.271
Placebo - SjS
-1.58
± 6.052
MHV370 200mg - MCTD
15.50
± 9.192
Placebo - MCTD
-3.00
Week 8
Group
Value
95% CI
MHV370 200mg - SjS
3.14
± 5.928
Placebo - SjS
-2.80
± 4.185
MHV370 200mg - MCTD
20.00
± 7.071
Placebo - MCTD
-2.00
Week 12
Group
Value
95% CI
MHV370 200mg - SjS
-1.25
± 6.702
Placebo - SjS
2.71
± 8.826
MHV370 200mg - MCTD
20.00
Week 20
Group
Value
95% CI
MHV370 200mg - SjS
-9.42
Placebo - SjS
4.80
± 8.758
MHV370 200mg - MCTD
23.00
Week 24
Group
Value
95% CI
Placebo - SjS
5.75
± 10.782
MHV370 200mg - MCTD
30.00
SjS and MCTD Participants: Change From Baseline in Physician Global Assessment (PhGA)Secondary· 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.
Week 4
Group
Value
95% CI
MHV370 200mg - SjS
-1.75
± 12.658
Placebo - SjS
-5.25
± 11.185
MHV370 200mg - MCTD
-20.50
± 12.021
Placebo - MCTD
-15.00
Week 8
Group
Value
95% CI
MHV370 200mg - SjS
2.57
± 12.608
Placebo - SjS
-8.90
± 11.474
MHV370 200mg - MCTD
-39.00
± 18.385
Placebo - MCTD
-12.50
Week 12
Group
Value
95% CI
MHV370 200mg - SjS
-4.00
± 20.559
Placebo - SjS
-19.43
± 14.328
MHV370 200mg - MCTD
-66.00
Week 20
Group
Value
95% CI
MHV370 200mg - SjS
3.00
Placebo - SjS
-14.60
± 22.423
MHV370 200mg - MCTD
-64.00
Week 24
Group
Value
95% CI
Placebo - SjS
-30.75
± 19.534
MHV370 200mg - MCTD
-62.00
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Disease Activity Index (ESSDAI)Secondary· 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.
Week 4
Group
Value
95% CI
MHV370 200mg - SjS
-0.25
± 1.753
Placebo - SjS
-3.67
± 9.355
Week 8
Group
Value
95% CI
MHV370 200mg - SjS
0.57
± 6.528
Placebo - SjS
-4.80
± 11.487
Week 12
Group
Value
95% CI
MHV370 200mg - SjS
-3.00
± 4.583
Placebo - SjS
-3.43
± 7.656
Week 20
Group
Value
95% CI
MHV370 200mg - SjS
-2.00
Placebo - SjS
0.00
± 14.629
Week 24
Group
Value
95% CI
Placebo - SjS
-0.25
± 11.117
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI)Secondary· 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 s
Week 4
Group
Value
95% CI
MHV370 200mg - SjS
-0.12
± 0.354
Placebo - SjS
-0.53
± 1.105
Week 8
Group
Value
95% CI
MHV370 200mg - SjS
-0.67
± 0.793
Placebo - SjS
-0.37
± 1.511
Week 12
Group
Value
95% CI
MHV370 200mg - SjS
-0.42
± 0.500
Placebo - SjS
-1.38
± 1.976
Week 20
Group
Value
95% CI
MHV370 200mg - SjS
-0.17
Placebo - SjS
-2.20
± 1.865
Week 24
Group
Value
95% CI
Placebo - SjS
-2.00
± 2.000
SjS Participants: Change From Baseline to the Salivary Flow RateSecondary· 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.
Week 4
Group
Value
95% CI
MHV370 200mg - SjS
0.162
± 0.2735
Placebo - SjS
-0.127
± 0.7914
Week 12
Group
Value
95% CI
MHV370 200mg - SjS
0.144
± 0.2109
Placebo - SjS
0.183
± 0.3944
Week 24
Group
Value
95% CI
Placebo - SjS
0.564
± 0.9193
SjS Participants: Change From Baseline to the Schirmer's TestSecondary· Baseline, Week 4, 12 and 24
Schirmer's test is used to determine whether the eye produces enough tears to keep it moist especially for those who suffer from dry eye syndrome. A strip is placed in the lower eyelid for 5 minutes to assess tear production. After 5 minutes, the filter paper is removed and the distance between the leading edge of wetness and the initial fold is measured, using a millimeter ruler. Tear deficiency is defined as \<5 mm wetting of the paper after 5 minutes.
Week 4, right eye
Group
Value
95% CI
MHV370 200mg - SjS
-1.5
± 4.87
Placebo - SjS
0.0
± 3.59
Week 12, right eye
Group
Value
95% CI
MHV370 200mg - SjS
-1.0
± 2.16
Placebo - SjS
5.3
± 8.81
Week 24, right eye
Group
Value
95% CI
Placebo - SjS
-3.0
± 6.32
Week 4, left eye
Group
Value
95% CI
MHV370 200mg - SjS
1.1
± 1.96
Placebo - SjS
1.6
± 6.01
Week 12, left eye
Group
Value
95% CI
MHV370 200mg - SjS
2.0
± 1.83
Placebo - SjS
4.9
± 12.50
Week 24, left eye
Group
Value
95% CI
Placebo - SjS
-1.0
± 2.94
SjS Participants: Sjögren's Tool for Assessing Response (STAR) Response Over Time up to Week 24Secondary· Baseline, Week 4, 12 and 24
STAR is a composite responder index, including in a single tool all main disease features, and designed for use as a key efficacy endpoint in SjS Domain Point Definition of response.
Points are assigned in the following 5 domains, if the corresponding criteria are met:
* Systemic activity, if decrease in clin ESSDAI ≥ 3 points: 3 points
* Patient reported outcome, if decrease in ESSPRI ≥ 1 point or 15%: 3 points
* Lacrimal gland function (assessed by Schirmer's test), if abnormal score at baseline: increase ≥ 5 mm from baseline OR if normal score at baseline: no change to abnormal: 1 point
*
Week 4
Group
Value
95% CI
MHV370 200mg - SjS
0
Placebo - SjS
3
Week 12
Group
Value
95% CI
MHV370 200mg - SjS
1
Placebo - SjS
4
Week 24
Group
Value
95% CI
MHV370 200mg - SjS
0
Placebo - SjS
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 199 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study was a basket trial designed to establish safety, tolerability and efficacy of MHV370 in Sjögren's Syndrome (SjS) and Mixed Connective Tissue Disease (MCTD).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 9 October 2024
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