Clinical Trial Results:
Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study
Summary
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EudraCT number |
2020-004355-33 |
Trial protocol |
BE CZ PL |
Global end of trial date |
23 May 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jun 2024
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First version publication date |
05 Jun 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MH002-UC-201
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
MRM Health NV
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Sponsor organisation address |
Technologiepark-Zwijnaarde 82, Ghent, Belgium, B-9052
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Public contact |
MH002-FIH Information Desk, MRM Health NV, +32 92411188, MH002-FIH@mrmhealth.com
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Scientific contact |
MH002-FIH Information Desk, MRM Health NV, +32 92411188, MH002-FIH@mrmhealth.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Aug 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 May 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
23 May 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
• To evaluate the safety and tolerability of MH002 in subjects with mild to moderate ulcerative colitis (UC)
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Protection of trial subjects |
The study was conducted in accordance with the protocol, ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences, International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and other Guidelines, and applicable laws and regulations.
The study protocol, all study protocol amendments, written study subject information, informed consent form (ICF), Investigator’s Brochure, and any other relevant documents were reviewed and approved by an independent ethics committee (IEC) at each study center. The investigator informed the subjects of the risks and benefits of the study. The subjects were informed that they could withdraw from the study at any time for any reason. Consent was obtained in writing prior to any study-related activities; the investigator retained a copy of the ICFs.
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Background therapy |
Yes | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 36
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Country: Number of subjects enrolled |
Belgium: 4
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Country: Number of subjects enrolled |
Czechia: 5
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Worldwide total number of subjects |
45
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EEA total number of subjects |
45
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
42
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled at study sites in Poland, Belgium and Czechia. The first ICF was signed on 03 November 2021. The last study visit occurred on 23 May 2023. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
75 subjects were screened. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Period 1: Weeks 1-8 (randomized phase)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Investigator, Monitor, Data analyst, Carer, Subject, Assessor | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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MH002 | ||||||||||||||||||||||||
Arm description |
MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase). | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
MH002
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
400 mg daily with the first meal of the day
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Arm title
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Placebo | ||||||||||||||||||||||||
Arm description |
Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase). | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
MH002-matching Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
400 mg daily with the first meal of the day
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Period 2
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Period 2 title |
Period 2: Weeks 9-16 (extension phase)
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Is this the baseline period? |
No | ||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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MH002-MH002 | ||||||||||||||||||||||||
Arm description |
MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase). Note: One subject completed study period 1, but did not start study period 2 due to withdrawal of consent. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
MH002
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
400 mg daily with the first meal of the day
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Arm title
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Placebo-Placebo (Placebo responders) | ||||||||||||||||||||||||
Arm description |
Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase). Note: One subject completed study period 1, but did not start study period 2 due to withdrawal of consent. | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
MH002-matching Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
400 mg daily with the first meal of the day
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Arm title
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Placebo-MH002 (Placebo non-responders) | ||||||||||||||||||||||||
Arm description |
Placebo during Weeks 1–8 (randomized phase); non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9–16 (extension phase). | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
MH002
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
400 mg daily with the first meal of the day
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Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: MH002-MH002: one subject completed study period 1, but did not start study period 2 due to withdrawal of consent. Placebo-Placebo: one subject completed study period 1, but did not start study period 2 due to withdrawal of consent. |
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Baseline characteristics reporting groups
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Reporting group title |
MH002
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Reporting group description |
MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MH002
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Reporting group description |
MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase). | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase). | ||
Reporting group title |
MH002-MH002
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Reporting group description |
MH002 during Weeks 1-8 (randomized phase); responders and non-responders received MH002 during Weeks 9-16 (extension phase). Note: One subject completed study period 1, but did not start study period 2 due to withdrawal of consent. | ||
Reporting group title |
Placebo-Placebo (Placebo responders)
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Reporting group description |
Placebo during Weeks 1–8 (randomized phase); responders (based on Modified Mayo Score using locally read colonoscopy or Physician’s Global Assessment in case of missing data) remained on Placebo until Week 16, while non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9-16 (extension phase). Note: One subject completed study period 1, but did not start study period 2 due to withdrawal of consent. | ||
Reporting group title |
Placebo-MH002 (Placebo non-responders)
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Reporting group description |
Placebo during Weeks 1–8 (randomized phase); non-responders were automatically (blindly) allocated to MH002 400 mg daily during Weeks 9–16 (extension phase). |
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End point title |
Incidence of Treatment-emergent Adverse Events (TEAEs) [1] | |||||||||
End point description |
Treatment-emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened in severity after the first administration of study treatment and prior to 30 days after the last administration of study treatment, or up to the last safety phone call assessment scheduled 21 days (or up to 28 days) after Week 16/Early Discontinuation Visit (whichever comes first).
Population: Safety Analysis Set; all subjects who enrolled in the study and received at least 1 dose of study treatment.
For subjects who were randomized to Placebo in the randomized phase and who switched at Week 8 to MH002 in the extension phase, TEAEs that first occurred or worsened after initiation of MH002 were identified and summarized separately.
Notes:
No statistical analyses have been specified for this primary endpoint. Justification: no statistical analysis was intended to be performed for this endpoint.
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End point type |
Primary
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End point timeframe |
From first dose up to Week 19 (20).
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Primary endpoint: safety and tolerability. No formal hypothesis testing was planned, any statistical testing is to be considered exploratory and descriptive in this study. The sample size is not based on statistical considerations but practical ones. |
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No statistical analyses for this end point |
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End point title |
Change from baseline in Modified Mayo Score (MMS) at Week 8 | ||||||||||||
End point description |
The 3-item Modified Mayo Score (MMS) is a composite scoring index based on sum of the Mayo symptom subscores for stool frequency and rectal bleeding, and centrally assessed Mayo Endoscopic Score (MES), ie, without the Physician’s Global Assessment of disease activity (0-9: normal to severe UC).
Population: Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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End point type |
Secondary
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End point timeframe |
Week 8
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Statistical analysis title |
CFBL in Modified Mayo Score (MMS) | ||||||||||||
Statistical analysis description |
Changes from baseline (CFBL) were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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Comparison groups |
MH002 v Placebo
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Number of subjects included in analysis |
37
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.2457 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
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End point title |
Change from baseline in Mayo symptom subscore for stool frequency at Week 8 | ||||||||||||
End point description |
Patient-reported disease symptom assessment of stool frequency (0-3: none to most frequent).
Population: Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Last Observation Carried Forward (LOCF).
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End point type |
Secondary
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End point timeframe |
Week 8
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Statistical analysis title |
CFBL in Mayo subscore for stool frequency | ||||||||||||
Statistical analysis description |
Changes from baseline (CFBL) were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Last Observation Carried Forward (LOCF).
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Comparison groups |
MH002 v Placebo
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.3233 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
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End point title |
Change from baseline in Mayo symptom subscore for rectal bleeding at Week 8 | ||||||||||||
End point description |
Patient-reported disease symptom assessment of rectal bleeding (0-3: none to most severe).
Population: Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Last Observation Carried Forward (LOCF).
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End point type |
Secondary
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End point timeframe |
Week 8
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Statistical analysis title |
CFBL in Mayo subscore for rectal bleeding | ||||||||||||
Statistical analysis description |
Changes from baseline (CFBL) were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Last Observation Carried Forward (LOCF).
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Comparison groups |
MH002 v Placebo
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.5373 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Change from baseline in Mayo Endoscopic Score (MES) (overall) at Week 8 | ||||||||||||
End point description |
The Mayo Endoscopic Score (MES) is a well-established endoscopic scoring index (centrally assessed; 0-3: normal to severe disease).
Population: Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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End point type |
Secondary
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End point timeframe |
Week 8
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Statistical analysis title |
CFBL in Mayo Endoscopic Score (MES) | ||||||||||||
Statistical analysis description |
Changes from baseline (CFBL) were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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Comparison groups |
MH002 v Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0543 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Rate of Modified Mayo Score (MMS) Clinical Response at Week 8 | |||||||||
End point description |
Clinical Response is a composite scoring index and defined as a decrease of ≥3 points on the Modified Mayo Score (MMS) and/or a decrease of ≥1 point on the Mayo symptom subscore for stool frequency and a decrease of ≥1 point on the Mayo symptom subscore for rectal bleeding, and/or meeting the definition of clinical remission.
Population: Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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End point type |
Secondary
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End point timeframe |
Week 8
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Statistical analysis title |
Rate of Clinical Response | |||||||||
Statistical analysis description |
Percentage rates were compared between MH002 and Placebo.
The Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant corticosteroid use and included continuity correction.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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Comparison groups |
MH002 v Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.5943 | |||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||
Confidence interval |
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End point title |
Rate of Modified Mayo Score (MMS) Clinical Remission at Week 8 | |||||||||
End point description |
Clinical Remission is a composite scoring index and defined as Modified Mayo Score (MMS) ≤2.0 and with all MMS subscores ≤1 and a Mayo symptom subscore for rectal bleeding of 0.
Population: Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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End point type |
Secondary
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End point timeframe |
Week 8
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Statistical analysis title |
Rate of Clinical Remission | |||||||||
Statistical analysis description |
Percentage rates were compared between MH002 and Placebo.
The Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant corticosteroid use and included continuity correction.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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Comparison groups |
MH002 v Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.4597 | |||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||
Confidence interval |
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End point title |
Changes from baseline in histologic scores (Nancy Index, Geboes Score, and Robarts' Histopathology Index) of colonic biopsies at Week 8 | |||||||||||||||||||||
End point description |
Histologic scoring tools to assess histopathological disease activity in patients with Ulcerative Colitis; scores define histological inflammation and remission of the mucosa.
Nancy Index: grades 0-4; least to most severe disease.
Geboes Score: grades 0.0-5.4; no to most severe histological inflammation.
Robarts' Histopathology Index (RHI): 0-33; no to most severe disease activity.
Population: Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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End point type |
Secondary
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End point timeframe |
Week 8
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Statistical analysis title |
CFBL in histologic score: Nancy Index | |||||||||||||||||||||
Statistical analysis description |
Changes from baseline (CFBL) were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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Comparison groups |
MH002 v Placebo
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Number of subjects included in analysis |
41
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||
P-value |
= 0.6431 | |||||||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||||||||||||||
Confidence interval |
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Statistical analysis title |
CFBL in histologic score: Geboes Score | |||||||||||||||||||||
Statistical analysis description |
Changes from baseline (CFBL) were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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Comparison groups |
MH002 v Placebo
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Number of subjects included in analysis |
41
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||
P-value |
= 0.5724 | |||||||||||||||||||||
Method |
t-test, 1-sided | |||||||||||||||||||||
Confidence interval |
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Statistical analysis title |
CFBL in histologic score: RHI | |||||||||||||||||||||
Statistical analysis description |
Changes from baseline (CFBL) were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
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Comparison groups |
MH002 v Placebo
|
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Number of subjects included in analysis |
41
|
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Analysis specification |
Pre-specified
|
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Analysis type |
superiority | |||||||||||||||||||||
P-value |
= 0.796 | |||||||||||||||||||||
Method |
t-test, 1-sided | |||||||||||||||||||||
Confidence interval |
|
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End point title |
Change from baseline in stool consistency (Bristol Stool Form Scale) at Week 8 | ||||||||||||
End point description |
The Bristol Stool Form Scale (BSFS) is a 7-point scale used for stool consistency measurement (1-7: hard to watery).
Population: Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Last Observation Carried Forward (LOCF).
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End point type |
Secondary
|
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End point timeframe |
Week 8
|
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|
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Statistical analysis title |
CFBL in stool consistency (BSFS) | ||||||||||||
Statistical analysis description |
Changes from baseline were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Last Observation Carried Forward (LOCF).
|
||||||||||||
Comparison groups |
MH002 v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.2485 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
|
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End point title |
Change from baseline in faecal calprotectin at Week 8 | ||||||||||||
End point description |
Faecal calprotectin is a clinically relevant marker of intestinal inflammation and is recommended in daily clinical practice for follow-up of patients with Ulcerative Colitis and to guide treatment decisions.
Population: Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Week 8
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
CFBL in faecal calprotectin | ||||||||||||
Statistical analysis description |
Changes from baseline (CFBL) were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
|
||||||||||||
Comparison groups |
MH002 v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.2043 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Changes from baseline in C-reactive protein (CRP) at Week 8 | ||||||||||||
End point description |
C-reactive Protein (CRP) is an acute-phase protein produced by the liver in response to various acute and chronic inflammatory conditions and is a widely used serum indicator of inflammation in Ulcerative Colitis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Week 8
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
CFBL in C-reactive Protein (CRP) | ||||||||||||
Statistical analysis description |
Changes from baseline (CFBL) were compared between MH002 and Placebo.
Full Analysis Set; all subjects randomly assigned to study treatment.
Analysis by Observed Cases (OC).
|
||||||||||||
Comparison groups |
MH002 v Placebo
|
||||||||||||
Number of subjects included in analysis |
45
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.1899 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|
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Adverse events information
|
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Timeframe for reporting adverse events |
From first study drug administration up to Week 19 (20).
|
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Adverse event reporting additional description |
Adverse Events: Safety Analysis Set for the study included all subjects who took at least 1 dose of study treatment.
|
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.1
|
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Reporting groups
|
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Reporting group title |
MH002
|
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Reporting group description |
All subjects who were randomized to MH002 on Day 1 and who were allocated to MH002 during Weeks 1-16. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
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Reporting group description |
All subjects who were randomized to Placebo on Day 1 and who were allocated to Placebo during Weeks 1–8 (randomized phase); with responders remaining on Placebo until Week 16. For subjects who were randomized to Placebo in the randomized phase and who switched at Week 8 to MH002 in the extension phase (Placebo non-responders), TEAEs that first occurred or worsened after initiation of MH002 were identified and summarized separately. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
This trial with relative small sample size was primarily intended to assess the safety and tolerability of MH002 in subjects with mild-to-moderate Ulcerative Colitis. Endpoints related to disease activity were exploratory in nature. |