Trial · NCT04440592

Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

NCT04440592, Phase 2, Completed, Tanabe Pharma America, Inc.; results first posted 2025-11-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis. Trials, record NCT04440592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04440592

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
NCT number: NCT04440592
Status: Completed
Phases: Phase 2
Enrollment: 76 participants, actual
Lead sponsor: Tanabe Pharma America, Inc.
Conditions: Diffuse Cutaneous Systemic Sclerosis
Interventions: MT-7117, Placebo
First posted: 2020-06-19
Last updated: 2025-12-30
Results first posted: 2025-11-03

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The ACR CRISS Composite Score (0-1) at Week 52	Week 52	The comparison between MT-7117 treatment group and placebo group will be performed. The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.
Secondary	Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	52 weeks	To evaluate the efficacy of MT 7117 treatment for up to 52 weeks using the Health Assessment Questionnaire Disability Index (HAQ DI). The Health Assessment Questionnaire Disability Index (HAQ-DI) is a self-administered instrument consists of 20 questions referring to eight component sets consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored on a 4-point scale from 0 to 3: 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. Overall score was computed as the sum of component set scores and divided by the number of component sets answered. This outcome measure represents the change in mean score from baseline. A negative change from baseline indicates improvement.
Secondary	Change in Percent Predicted Forced Vital Capacity (%pFVC) From Baseline up to Week 52	52 weeks	To evaluate the efficacy of MT-7117 treatment for up to 52 weeks on pulmonary function as measured by percent predicted forced vital capacity (%pFVC)
Secondary	Change in Patient Global Assessment From Baseline up to Week 52	52 weeks	To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using the Patient Global Assessment
Secondary	Change in Physician Global Assessment From Baseline up to Week 52	52 weeks	To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using the Physician Global Assessment. The Physician Global Assessment is used to assess the physician's rating of overall health of the subject. Physicians rate the perceived health of the subject on an 11-point scale from 0 (excellent) to 10 (extremely poor).
Secondary	Change in Modified Rodnan Skin Score (mRSS) From Baseline From Baseline up to Week 52	52 weeks	To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using the modified Rodnan Skin Score (mRSS). mRSS evaluates a subject's skin thickness which will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites. The total score is the sum of the individual skin scores from all of these sites and ranges from 0 to 51 units.
Secondary	ACR CRISS Score up to Week 39	39 weeks	To evaluate the efficacy of MT 7117 treatment for up to 39 weeks using the ACR CRISS Score. The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.
Secondary	ACR CRISS Score Responder (CRISS>=0.6) From Baseline up to Week 52	52 weeks	To evaluate the efficacy of MT-7117 treatment for up to 52 weeks using CRISS Score. Subjects with CRISS score is \>=0.60 are considered improved, while subjects with CRISS score \< 0.60 are considered not improved.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The ACR CRISS Composite Score (0-1) at Week 52	Week 52	Reason of discrepancy between Number analyzed and Overall Number of Participants Analyzed: The analysis was performed only in patients who have data at week 52.	scores on ascale	MEDIAN
SECONDARY	Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	52 weeks	The analysis was performed only in patients who have data at each week.	score on a scale	MEAN
SECONDARY	Change in Percent Predicted Forced Vital Capacity (%pFVC) From Baseline up to Week 52	52 weeks	Reason of discrepancy between Number analyzed of each row and Overall Number of Participants Analyzed: The analysis was performed only in patients who have data at each week.	%pFVC	MEAN
SECONDARY	Change in Patient Global Assessment From Baseline up to Week 52	52 weeks	Reason of discrepancy between Number analyzed of each row and Overall Number of Participants Analyzed: The analysis was performed only in patients who have data at each week.	score on a scale	MEAN
SECONDARY	Change in Physician Global Assessment From Baseline up to Week 52	52 weeks	Reason of discrepancy between Number analyzed of each row and Overall Number of Participants Analyzed: The analysis was performed only in patients who have data at each week.	score on a scale	MEAN
SECONDARY	Change in Modified Rodnan Skin Score (mRSS) From Baseline From Baseline up to Week 52	52 weeks	Reason of discrepancy between Number analyzed of each row and Overall Number of Participants Analyzed: The analysis was performed only in patients who have data at each week.	score on a scale	MEAN
SECONDARY	ACR CRISS Score up to Week 39	39 weeks	Reason of discrepancy between Number analyzed of each row and Overall Number of Participants Analyzed: The analysis was performed only in patients who have data at each week.	scores on ascale	MEDIAN
SECONDARY	ACR CRISS Score Responder (CRISS>=0.6) From Baseline up to Week 52	52 weeks	Reason of discrepancy between Number analyzed of each row and Overall Number of Participants Analyzed: The analysis was performed only in patients who have data at each week.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The ACR CRISS Composite Score (0-1) at Week 52	MT-7117		0.8537	Full Range 0.000 to 1.000	scores on ascale
The ACR CRISS Composite Score (0-1) at Week 52	Placebo		0.8502	Full Range 0.000 to 1.000	scores on ascale
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	MT-7117	Change from baseline (BL) at Week 16	-0.1439	Standard Deviation 0.3803	score on a scale
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	Placebo	Change from baseline (BL) at Week 16	-0.0395	Standard Deviation 0.3900	score on a scale
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	MT-7117	Change from BL at Week 26	-0.0847	Standard Deviation 0.3360	score on a scale
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	Placebo	Change from BL at Week 26	-0.0691	Standard Deviation 0.4481	score on a scale
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	MT-7117	Change from BL at Week 39	-0.0927	Standard Deviation 0.3178	score on a scale
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	Placebo	Change from BL at Week 39	-0.0439	Standard Deviation 0.5147	score on a scale
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	MT-7117	Change from BL at Week 52	-0.1111	Standard Deviation 0.4265	score on a scale
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline up to Week 52	Placebo	Change from BL at Week 52	-0.0208	Standard Deviation 0.5102	score on a scale

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	MT-7117	38
Overall Study	STARTED	Placebo	38
Overall Study	COMPLETED	MT-7117	28
Overall Study	COMPLETED	Placebo	36
Overall Study	NOT COMPLETED	MT-7117	10
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events78

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
other	Cataract	Eye disorders	MT-7117	0	38
other	Cataract	Eye disorders	Placebo	2	38
other	Diarrhoea	Gastrointestinal disorders	MT-7117	10	38
other	Diarrhoea	Gastrointestinal disorders	Placebo	5	38
other	Dysphagia	Gastrointestinal disorders	MT-7117	2	38
other	Dysphagia	Gastrointestinal disorders	Placebo	1	38
other	Nausea	Gastrointestinal disorders	MT-7117	7	38
other	Nausea	Gastrointestinal disorders	Placebo	2	38
other	Vomiting	Gastrointestinal disorders	MT-7117	6	38
other	Vomiting	Gastrointestinal disorders	Placebo	2	38

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MT-7117	0	38
Total, all-cause mortality	Placebo	0	38
Total, other adverse events	MT-7117	35	38
Total, other adverse events	Placebo	28	38
Total, serious adverse events	MT-7117	4	38
Total, serious adverse events	Placebo	2	38

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39887900	DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
MT-7117 vs Placebo: deaths from any cause	Trial comparisons
MT-7117 vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

GET https://conductscience.org/api/trials/v1/NCT04440592

GET https://conductscience.org/api/trials/v1/NCT04440592/results?page=2

API reference For AI assistants