A Phase 2 interventional study of MHV370 and Placebo in Sjogren Syndrome and Mixed Connective Tissue Disease, sponsored by Novartis Pharmaceuticals. Terminated at 10 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
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).
This was a randomized, participant and investigator blinded, placebo-controlled, multi center parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren's Syndrome (SjS) or with Mixed Connective Tissue Disease (MCTD). Participants first underwent a screening period of up to 6 weeks, followed by a treatment duration of 24 weeks and a follow-up period of 4 weeks. Total study duration for each participant was up to 34 weeks. Participants with SjS were randomized in a 1:1 ratio to MHV370 or placebo and participants with MCTD were randomized in a 1:1 ratio to MHV370 or placebo.
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SjS and MCTD:
SjS:
MCTD:
Exclusion Criteria:
SjS and MCTD:
SjS:
Other protocol-defined inclusion/exclusion criteria may apply
SjS participants randomized in the MHV370 arm will be treated with MHV370 for 24 weeks. Double-blind supply will be used.
Drug: MHV370
SjS participants randomized in the placebo arm will be treated with placebo for 24 weeks. Double-blind supply will be used.
Drug: Placebo
MCTD participants randomized in the MHV370 arm will be treated with MHV370 for 24 weeks. Double-blind supply will be used.
Drug: MHV370
MCTD participants randomized in the placebo arm will be treated with placebo for 24 weeks. Double-blind supply will be used.
Drug: Placebo
MHV370 for 24 weeks
Placebo for 24 weeks
SjS Participants: Change From Baseline in Eular Sjögren's Disease Activity Index (ESSDAI) After 24 Weeks of Treatment
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.
Time frame: Baseline, Week 24
MCTD Participants: Change From Baseline in Physician's Global Assessment Scale (PhGA) After 24 Weeks of Treatment
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.
Time frame: Baseline, Week 24
SjS and MCTD Participants: Maximum Observed Plasma Concentrations (Cmax) of MHV370 at Steady State
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.
Time frame: pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4
SjS and MCTD Participants: Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours (AUC0-6h) of MHV370
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.
Time frame: pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4
SjS and MCTD Participants: Time to Reach Maximum Plasma Concentrations (Tmax) of MHV370 at Steady State
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.
Time frame: pre-dose, 0.5, 1, 2 ,4 and 6 hours after dosing at week 4
SjS and MCTD Participants: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale
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.
Time frame: Baseline, Weeks 4, 8, 12, 20 and 24
SjS and MCTD Participants: Change From Baseline in Physician Global Assessment (PhGA)
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.
Time frame: Baseline, Weeks 4, 8, 12, 20 and 24
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Disease Activity Index (ESSDAI)
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.
Time frame: Baseline, Weeks 4, 8, 12, 20 and 24
SjS Participants: Change From Baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI)
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.
Time frame: baseline, weeks 4, 8, 12, 20 and 24
SjS Participants: Change From Baseline to the Salivary Flow Rate
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.
Time frame: Baseline, Weeks 4, 12 and 24
SjS Participants: Change From Baseline to the Schirmer's Test
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.
Time frame: Baseline, Week 4, 12 and 24
SjS Participants: Sjögren's Tool for Assessing Response (STAR) Response Over Time up to Week 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 * Salivary gland function (assessed by unstimulated salivary flow), if increase ≥ 25% from baseline: 1 point * Biological (assessed by serum IgG levels), if decrease ≥ 10%: 1 point The Total Score is the sum of all 5 domain scores, ranging from 0 to 9 points. A STAR responder is defined as ≥ 5 points in the Total Score.
Time frame: Baseline, Week 4, 12 and 24
MCTD: Change From Baseline in Articular and Pulmonary Domains of the Eular Sjögren's Syndrome Disease Activity Index (ESSDAI)
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. Participants with Mixed Connective Tissue Disease (MCTD) completed the articular (from 0 "no activity" to 3 "high activity") and pulmonary (from 0 "no activity to 3 "high activity") domains of the ESSDAI only. For MCTD participants, the score range is 0-21, where a higher score indicates more severe symptoms. A negative change score from baseline indicates improvement.
Time frame: Baseline, Weeks 4, 8, 12 and 24
MCTD Participants: Change From Baseline in Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. A positive change from baseline is considered a favorable outcome.
Time frame: Baseline, Week 12
MCTD Participants: Change From Baseline in Forced Expiratory Volume During the First Second (FEV1) of a Forced Breath
FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV1 is considered a favourable outcome.
Time frame: Baseline, Week 12
MCTD Participants: Change From Baseline in Forced Expiratory Volume During the First Two Seconds (FEV2) of a Forced Breath
FEV2 (forced expiratory volume in two seconds) is the amount of air which can be forcibly exhaled from the lungs in the first two seconds of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV2 is considered a favourable outcome.
Time frame: Baseline, Week 12
MCTD Participants: Change From Baseline in Forced Expiratory Volume During the First Three Seconds (FEV3) of a Forced Breath
FEV3 (forced expiratory volume in three seconds) is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV3 is considered a favourable outcome.
Time frame: Baseline, Week 12
MCTD Participants: Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement to assess the ability of the lungs to transfer gas from inspired air to the bloodstream. Inhaled carbon monoxide (CO) is used for this test due to its high affinity for hemoglobin. During a ten-second breath-hold, DLCO measures uptake of CO per time per CO pressure. The outcome is presented as percentage of predicted DLCO value.
Time frame: Baseline, Week 24
MCTD Participants: Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD)
The K-BILD questionnaire is a self-administered health-status questionnaire that has been developed in patients with interstitial lung diseases. It consists of 15 items in three domains: breathlessness and activities, psychological factors, and chest symptoms. Total scores range from 0 to 100, with higher scores representing better health status.
Time frame: Baseline, Weeks 4, 8, 12 and 24
MCTD Participants: Change From Baseline in Raynaud's Condition Score (RCS)
The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon and impact of Raynaud's alone on use of hands every day. An 11-point Likert scale is used to rate the difficulty caused by the condition with 0 = no difficulty and 10 = extreme difficulty. Participants are asked to select the number that best describes their difficulty, with higher score indicating worse condition.
Time frame: Baseline, Weeks 4, 12 and 24
Participants took part in 10 investigative sites in 6 countries/regions.
| Milestone | MHV370 200mg - SjS | Placebo - SjS | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|---|---|
| Started | 12 | 14 | 2 | 2 |
| Completed | 0 | 4 | 1 | 0 |
| Not completed | 12 | 10 | 1 | 2 |
| Withdrew: Adverse event | 4 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 |
| Withdrew: Technical problems | 7 | 9 | 1 | 2 |
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.
| Score on scale | MHV370 200mg - SjS | Placebo - SjS |
|---|---|---|
| SjS Participants: Change From Baseline in Eular Sjögren's Disease Activity Index (ESSDAI) After 24 Weeks of Treatment | — | -4.39 ± 2.41 |
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.
| Score on scale | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|
| MCTD Participants: Change From Baseline in Physician's Global Assessment Scale (PhGA) After 24 Weeks of Treatment | -62.00 (-62.00 to -62.00) | — |
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.
| ng/mL | MHV370 200mg - SjS | MHV370 200mg - MCTD |
|---|---|---|
| SjS and MCTD Participants: Maximum Observed Plasma Concentrations (Cmax) of MHV370 at Steady State | 278 ± 85.7 | 194 |
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.
| ng*h/mL | MHV370 200mg - SjS | MHV370 200mg - MCTD |
|---|---|---|
| SjS and MCTD Participants: Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours (AUC0-6h) of MHV370 | 1060 ± 462 | 742 |
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.
| hours | MHV370 200mg - SjS | MHV370 200mg - MCTD |
|---|---|---|
| SjS and MCTD Participants: Time to Reach Maximum Plasma Concentrations (Tmax) of MHV370 at Steady State | 1.50 (1.00 to 4.00) | 2.00 |
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.
| Score on scale | MHV370 200mg - SjS | Placebo - SjS | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|---|---|
| Week 4 | 0.13 ± 3.271 | -1.58 ± 6.052 | 15.50 ± 9.192 | -3.00 |
| Week 8 | 3.14 ± 5.928 | -2.80 ± 4.185 | 20.00 ± 7.071 | -2.00 |
| Week 12 | -1.25 ± 6.702 | 2.71 ± 8.826 | 20.00 | — |
| Week 20 | -9.42 | 4.80 ± 8.758 | 23.00 | — |
| Week 24 | — | 5.75 ± 10.782 | 30.00 | — |
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.
| Score on scale | MHV370 200mg - SjS | Placebo - SjS | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|---|---|
| Week 4 | -1.75 ± 12.658 | -5.25 ± 11.185 | -20.50 ± 12.021 | -15.00 |
| Week 8 | 2.57 ± 12.608 | -8.90 ± 11.474 | -39.00 ± 18.385 | -12.50 |
| Week 12 | -4.00 ± 20.559 | -19.43 ± 14.328 | -66.00 | — |
| Week 20 | 3.00 | -14.60 ± 22.423 | -64.00 | — |
| Week 24 | — | -30.75 ± 19.534 | -62.00 | — |
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.
| Score on scale | MHV370 200mg - SjS | Placebo - SjS |
|---|---|---|
| Week 4 | -0.25 ± 1.753 | -3.67 ± 9.355 |
| Week 8 | 0.57 ± 6.528 | -4.80 ± 11.487 |
| Week 12 | -3.00 ± 4.583 | -3.43 ± 7.656 |
| Week 20 | -2.00 | 0.00 ± 14.629 |
| Week 24 | — | -0.25 ± 11.117 |
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.
| Score on scale | MHV370 200mg - SjS | Placebo - SjS |
|---|---|---|
| Week 4 | -0.12 ± 0.354 | -0.53 ± 1.105 |
| Week 8 | -0.67 ± 0.793 | -0.37 ± 1.511 |
| Week 12 | -0.42 ± 0.500 | -1.38 ± 1.976 |
| Week 20 | -0.17 | -2.20 ± 1.865 |
| Week 24 | — | -2.00 ± 2.000 |
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.
| mL/min | MHV370 200mg - SjS | Placebo - SjS |
|---|---|---|
| Week 4 | 0.162 ± 0.2735 | -0.127 ± 0.7914 |
| Week 12 | 0.144 ± 0.2109 | 0.183 ± 0.3944 |
| Week 24 | — | 0.564 ± 0.9193 |
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.
| milimeter | MHV370 200mg - SjS | Placebo - SjS |
|---|---|---|
| Week 4, right eye | -1.5 ± 4.87 | 0.0 ± 3.59 |
| Week 12, right eye | -1.0 ± 2.16 | 5.3 ± 8.81 |
| Week 24, right eye | — | -3.0 ± 6.32 |
| Week 4, left eye | 1.1 ± 1.96 | 1.6 ± 6.01 |
| Week 12, left eye | 2.0 ± 1.83 | 4.9 ± 12.50 |
| Week 24, left eye | — | -1.0 ± 2.94 |
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 * Salivary gland function (assessed by unstimulated salivary flow), if increase ≥ 25% from baseline: 1 point * Biological (assessed by serum IgG levels), if decrease ≥ 10%: 1 point The Total Score is the sum of all 5 domain scores, ranging from 0 to 9 points. A STAR responder is defined as ≥ 5 points in the Total Score.
| Participants | MHV370 200mg - SjS | Placebo - SjS |
|---|---|---|
| Week 4 | 0 | 3 |
| Week 12 | 1 | 4 |
| Week 24 | 0 | 2 |
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. Participants with Mixed Connective Tissue Disease (MCTD) completed the articular (from 0 "no activity" to 3 "high activity") and pulmonary (from 0 "no activity to 3 "high activity") domains of the ESSDAI only. For MCTD participants, the score range is 0-21, where a higher score indicates more severe symptoms. A negative change score from baseline indicates improvement.
| Score on scale | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|
| Week 4 - articular | 0.00 ± 0.000 | 0.00 |
| Week 8 - articular | -1.00 ± 0.000 | 0.00 |
| Week 12 - articular | -1.00 | — |
| Week 24 - articular | -2.00 | — |
| Week 4 - pulmonary | 0.00 ± 0.000 | 0.00 |
| Week 8 - pulmonary | -0.50 ± 0.707 | 0.00 |
| Week 12 - pulmonary | -1.00 | — |
| Week 24 - pulmonary | -1.00 | — |
Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. A positive change from baseline is considered a favorable outcome.
| liters (L) | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|
| MCTD Participants: Change From Baseline in Forced Vital Capacity (FVC) | 0.530 | — |
FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV1 is considered a favourable outcome.
| liters (L) | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|
| MCTD Participants: Change From Baseline in Forced Expiratory Volume During the First Second (FEV1) of a Forced Breath | 0.250 | — |
FEV2 (forced expiratory volume in two seconds) is the amount of air which can be forcibly exhaled from the lungs in the first two seconds of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV2 is considered a favourable outcome.
| liters (L) | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|
| MCTD Participants: Change From Baseline in Forced Expiratory Volume During the First Two Seconds (FEV2) of a Forced Breath | 0.410 | — |
FEV3 (forced expiratory volume in three seconds) is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV3 is considered a favourable outcome.
| liters (L) | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|
| MCTD Participants: Change From Baseline in Forced Expiratory Volume During the First Three Seconds (FEV3) of a Forced Breath | 0.460 | — |
Diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement to assess the ability of the lungs to transfer gas from inspired air to the bloodstream. Inhaled carbon monoxide (CO) is used for this test due to its high affinity for hemoglobin. During a ten-second breath-hold, DLCO measures uptake of CO per time per CO pressure. The outcome is presented as percentage of predicted DLCO value.
| percentage of predicted DLCO | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|
| Baseline | 84.0 | 95.5 ± 2.12 |
The K-BILD questionnaire is a self-administered health-status questionnaire that has been developed in patients with interstitial lung diseases. It consists of 15 items in three domains: breathlessness and activities, psychological factors, and chest symptoms. Total scores range from 0 to 100, with higher scores representing better health status.
| Score on scale | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|
| Week 4 | 3.00 ± 4.243 | -2.00 |
| Week 8 | 13.00 ± 9.899 | 0.00 |
| Week 12 | 21.00 | — |
| Week 24 | 58.00 | — |
The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon and impact of Raynaud's alone on use of hands every day. An 11-point Likert scale is used to rate the difficulty caused by the condition with 0 = no difficulty and 10 = extreme difficulty. Participants are asked to select the number that best describes their difficulty, with higher score indicating worse condition.
| Score on scale | MHV370 200mg - MCTD | Placebo - MCTD |
|---|---|---|
| Week 4 | -2.50 ± 3.536 | 1.00 |
| Week 12 | -1.00 | — |
| Week 24 | -2.00 | — |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| sjs_MHV | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| sjs_Placebo | 0/14 (0%) | 0/14 (0%) | 12/14 (85.7%) |
| MCTD_MHV | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| MCTD_Placebo | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Total | 0/30 (0%) | 1/30 (3.3%) | 27/30 (90%) |
| Event | sjs_MHV | sjs_Placebo | MCTD_MHV | MCTD_Placebo | Total |
|---|---|---|---|---|---|
| Ovarian cystReproductive system and breast disorders | 0/12 | 0/14 | 0/2 | 1/2 | 1/30 |
| Event | sjs_MHV | sjs_Placebo | MCTD_MHV | MCTD_Placebo | Total |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 2/12 | 4/14 | 0/2 | 2/2 | 8/30 |
| Abdominal painGastrointestinal disorders | 0/12 | 0/14 | 1/2 | 0/2 | 1/30 |
| DiarrhoeaGastrointestinal disorders | 1/12 | 1/14 | 0/2 | 1/2 | 3/30 |
| NauseaGastrointestinal disorders | 0/12 | 0/14 | 0/2 | 1/2 | 1/30 |
| Paraesthesia oralGastrointestinal disorders | 0/12 | 0/14 | 0/2 | 1/2 | 1/30 |
| Upper respiratory tract infectionInfections and infestations | 1/12 | 0/14 | 0/2 | 1/2 | 2/30 |
| Viral infectionInfections and infestations | 0/12 | 0/14 | 0/2 | 1/2 | 1/30 |
| Ovarian cystReproductive system and breast disorders | 0/12 | 0/14 | 0/2 | 1/2 | 1/30 |
| Dermatitis allergicSkin and subcutaneous tissue disorders | 0/12 | 0/14 | 1/2 | 0/2 | 1/30 |
| COVID-19Infections and infestations | 4/12 | 2/14 | 0/2 | 0/2 | 6/30 |
| Age, Continuous(years) | MHV370 200mg - SjS | Placebo - SjS | MHV370 200mg - MCTD | Placebo - MCTD | Total |
|---|---|---|---|---|---|
| Mean | 49.3 ± 12.20 | 54.7 ± 9.67 | 35.0 ± 12.73 | 44.0 ± 0.00 | 50.5 ± 11.52 |
| Sex: Female, Male(Participants) | MHV370 200mg - SjS | Placebo - SjS | MHV370 200mg - MCTD | Placebo - MCTD | Total |
|---|---|---|---|---|---|
| Female | 12 | 14 | 2 | 2 | 30 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | MHV370 200mg - SjS | Placebo - SjS | MHV370 200mg - MCTD | Placebo - MCTD | Total |
|---|---|---|---|---|---|
| Asian | 3 | 3 | 0 | 0 | 6 |
| White | 9 | 11 | 2 | 2 | 24 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Ran from Nov 2021 to primary completion in Feb 2023, 14 months.
Results were first posted in Jul 2024, 1 year 5 months after primary completion.
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