Trial · NCT03520036

Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria

NCT03520036, Phase 2, Completed, Tanabe Pharma America, Inc.; results first posted 2023-01-20

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 Erythropoietic Protoporphyria. Trials, record NCT03520036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03520036

On this page

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 Erythropoietic Protoporphyria
NCT number: NCT03520036
Status: Completed
Phases: Phase 2
Enrollment: 102 participants, actual
Lead sponsor: Tanabe Pharma America, Inc.
Conditions: Erythropoietic Protoporphyria (EPP)
Interventions: MT-7117 low dose, MT-7117 high dose, Placebo
First posted: 2018-05-09
Last updated: 2025-12-31
Results first posted: 2023-01-20

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Average Daily Time (Minutes) to First Prodromal Symptom Associated With Sunlight Exposure Between Hour Post Sunrise and 1 Hour Pre-Sunset at Week 16.	Baseline (Week 0) and Week 16	Duration in minutes, of sunlight exposure between 1 hour post sunrise and 1 hour pre-sunset. The average Duration in minutes, of sunlight exposure before the first prodromal symptom between 1 hour post sunrise and 1 hour pre-sunset. The average duration means that average of daily durations in 14-day windows before Day 1 (or week 16 Day) applied.
Primary	Change From Baseline in Average Daily Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	Baseline (Week 0), and Week 16	Change from baseline to week 16 in Average Daily Duration (Minutes) of Sunlight Exposure sums any sunlight exposure time excluding any overlapped time with prodromal symptoms, including if the patients go out multiple times on the same day after the prodromal symptom had previously ended.
Primary	Change From Baseline in Average Daily Mean Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	Baseline (Week 0), and Week 16	Change from baseline to week 16 in Average Daily Mean Duration (Minutes) of Sunlight Exposure without prodromal symptoms divided by the number of sunlight exposures periods applicable that day.
Secondary	Total Number of Sunlight Exposure Episodes With Prodromal Symptoms During 16-Week Double-Blind Treatment Period	Week 16
Secondary	Change From Baseline in Average Daily Mean Intensity of Prodromal Symptoms During 16-week Double-blind Treatment Period in 11-point Likert Scale	Baseline (Week 0), and Week 16	The Intensity of Prodromal Symptoms is measured by 11-point Likert scale ranges from 0 (no symptom) to 10 (greatest severity of symptom).
Secondary	Change From Baseline in Average Daily Duration (Minutes) of Prodromal Symptoms at 16-Week Double-Blind Treatment Period	Baseline (Week 0), and Week 16
Secondary	Change From Baseline in Pigmentation as Measured by Melanin Density for Average of 6 Skin Segments at Week 8 and Week 16.	Baseline (Week 0), Week 8, and Week 16	Pigmentation will be assessed in melanin density which are numeric scores measured by spectrophotometer on 6 skin segments (forehead, left cheek, right inside upper arm, left medial forearm, right-hand side of abdomen, and left-hand side of buttock).
Secondary	Percent Change From Baseline in Pigmentation as Measured by Melanin Density for Average of 6 Skin Segments at Week 8 and Week 16.	Baseline (Week 0), Week 8, and Week 16
Secondary	Total Number of Pain Events During 16-Week Double-Blind Treatment Period	Week 16
Other	Total Number of Sunlight Exposure Episodes	Baseline (Week 0) and Week 16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Average Daily Time (Minutes) to First Prodromal Symptom Associated With Sunlight Exposure Between Hour Post Sunrise and 1 Hour Pre-Sunset at Week 16.	Baseline (Week 0) and Week 16	ITT Population	Minutes	MEAN
PRIMARY	Change From Baseline in Average Daily Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	Baseline (Week 0), and Week 16	ITT Population	Minutes	MEAN
PRIMARY	Change From Baseline in Average Daily Mean Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	Baseline (Week 0), and Week 16	ITT Population	Minutes	MEAN
SECONDARY	Total Number of Sunlight Exposure Episodes With Prodromal Symptoms During 16-Week Double-Blind Treatment Period	Week 16	ITT Population	sunlight exposure episodes	MEAN
SECONDARY	Change From Baseline in Average Daily Mean Intensity of Prodromal Symptoms During 16-week Double-blind Treatment Period in 11-point Likert Scale	Baseline (Week 0), and Week 16	ITT Population	score on a scale	MEAN
SECONDARY	Change From Baseline in Average Daily Duration (Minutes) of Prodromal Symptoms at 16-Week Double-Blind Treatment Period	Baseline (Week 0), and Week 16	ITT Population	Minutes	MEAN
SECONDARY	Change From Baseline in Pigmentation as Measured by Melanin Density for Average of 6 Skin Segments at Week 8 and Week 16.	Baseline (Week 0), Week 8, and Week 16	ITT Population	unitless	MEAN
SECONDARY	Percent Change From Baseline in Pigmentation as Measured by Melanin Density for Average of 6 Skin Segments at Week 8 and Week 16.	Baseline (Week 0), Week 8, and Week 16	ITT Population	percent change	MEAN
SECONDARY	Total Number of Pain Events During 16-Week Double-Blind Treatment Period	Week 16	ITT Population	pain events	MEAN
OTHER_PRE_SPECIFIED	Total Number of Sunlight Exposure Episodes	Baseline (Week 0) and Week 16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group36

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Average Daily Time (Minutes) to First Prodromal Symptom Associated With Sunlight Exposure Between Hour Post Sunrise and 1 Hour Pre-Sunset at Week 16.	MT-7117 Low Dose	74.7	Standard Deviation 76.8	Minutes
Change From Baseline in Average Daily Time (Minutes) to First Prodromal Symptom Associated With Sunlight Exposure Between Hour Post Sunrise and 1 Hour Pre-Sunset at Week 16.	MT-7117 High Dose	92.4	Standard Deviation 100	Minutes
Change From Baseline in Average Daily Time (Minutes) to First Prodromal Symptom Associated With Sunlight Exposure Between Hour Post Sunrise and 1 Hour Pre-Sunset at Week 16.	Placebo	21.0	Standard Deviation 63.4	Minutes
Change From Baseline in Average Daily Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	MT-7117 Low Dose	72.6	Standard Deviation 76.2	Minutes
Change From Baseline in Average Daily Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	MT-7117 High Dose	86.1	Standard Deviation 83.9	Minutes
Change From Baseline in Average Daily Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	Placebo	19.9	Standard Deviation 63.2	Minutes
Change From Baseline in Average Daily Mean Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	MT-7117 Low Dose	70.2	Standard Deviation 73.4	Minutes
Change From Baseline in Average Daily Mean Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	MT-7117 High Dose	59.3	Standard Deviation 85.2	Minutes
Change From Baseline in Average Daily Mean Duration (Minutes) of Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-Sunset Without Prodromal Symptoms at Week 16	Placebo	12.8	Standard Deviation 46.9	Minutes
Total Number of Sunlight Exposure Episodes With Prodromal Symptoms During 16-Week Double-Blind Treatment Period	MT-7117 Low Dose	8.6	Standard Deviation 9.3	sunlight exposure episodes

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	MT-7117 Low Dose	33
Overall Study	STARTED	MT-7117 High Dose	34
Overall Study	STARTED	Placebo	35
Overall Study	COMPLETED	MT-7117 Low Dose	31
Overall Study	COMPLETED	MT-7117 High Dose	30
Overall Study	COMPLETED	Placebo	31
Overall Study	NOT COMPLETED	MT-7117 Low Dose	2
Overall Study	NOT COMPLETED	MT-7117 High Dose	4
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events276

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	Atrial fibrillation	Cardiac disorders	MT-7117 Low Dose	1	33
other	Atrial fibrillation	Cardiac disorders	MT-7117 High Dose	0	35
other	Atrial fibrillation	Cardiac disorders	Placebo	0	34
other	Congenital naevus	Congenital, familial and genetic disorders	MT-7117 Low Dose	1	33
other	Congenital naevus	Congenital, familial and genetic disorders	MT-7117 High Dose	0	35
other	Congenital naevus	Congenital, familial and genetic disorders	Placebo	0	34
other	Abdominal discomfort	Gastrointestinal disorders	MT-7117 Low Dose	1	33
other	Abdominal discomfort	Gastrointestinal disorders	MT-7117 High Dose	1	35
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	2	34
other	Abdominal pain	Gastrointestinal disorders	MT-7117 Low Dose	1	33

1 to 10 of 276Source ClinicalTrials.gov

See all 276 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MT-7117 Low Dose	0	33
Total, all-cause mortality	MT-7117 High Dose	0	35
Total, all-cause mortality	Placebo	0	34
Total, other adverse events	MT-7117 Low Dose	31	33
Total, other adverse events	MT-7117 High Dose	34	35
Total, other adverse events	Placebo	31	34
Total, serious adverse events	MT-7117 Low Dose	1	33
Total, serious adverse events	MT-7117 High Dose	0	35
Total, serious adverse events	Placebo	0	34

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37043653	RESULT	PubMed
39887900	DERIVED	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 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.

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/NCT03520036

GET https://conductscience.org/api/trials/v1/NCT03520036/results?page=2

API reference For AI assistants