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Strategic reasons
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This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active Crohn's disease or Ulcerative Colitis who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDGN-002 | Experimental | MDGN-002 will be supplied in vials of 150 mg/mL. MDGN-002 will be administered by SQ injection in the abdomen every 14 days at 1 of 2 dose levels: 1.0 mg/kg or 3.0 mg/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDGN-002 | Drug | MDGN-002 is a fully human IgG4 monoclonal antibody specific to human LIGHT. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) | The SES-CD is assessed through endoscopic review of 5 predefined gastrointestinal (GI) segments (ileum; right colon; transverse colon; left colon; rectum). For each segment, 4 endoscopic variables are assessed (presence of ulcers, ulcerated surface, affected surface, and presence of narrowing). Each variable is scored from 0 to 3 with higher scores indicating more severe symptoms. For each variable, the total score is calculated as the sum across all segments of the GI tract. The SES-CD total score, ranging from 0-60, is calculated as the sum of all variable total scores with a higher score indicating more severe endoscopic activity | Baseline to Visit 10 (Day 56) or early termination |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Crohn's Disease Activity Index (CDAI) | The Crohn's Disease Activity Index (CDAI) consists of the following 8 items: abdominal pain, number of liquid stools, general well-being, extraintestinal complication, use of antidiarrheal drugs, abdominal mass, hematocrit, and body weight. Information on abdominal pain, general well-being, and frequency of loose and watery stools was taken from a daily diary completed by the subject. Total CDAI scores can range from 0 to approximately 600 with higher scores indicating more active disease. Disease severity as measured by CDAI is categorized as: Remission (<150), Mildly active disease (150 - 219); Moderately active disease (220 - 450); Severe disease (> 450). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sweet Hope Research Specialty, Inc. | Hialeah | Florida | 33016 | United States | ||
| Advanced Research Institute, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | MDGN-002 1.0 mg/kg |
| FG001 | Cohort 2 | MDGN-002 3.0 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 23, 2021 | Sep 7, 2022 |
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| Baseline to Visit 10 (Day 56) or early termination. |
| Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q). | The IBD-Q is a 32-item questionnaire validated to measure quality of life in Crohn's disease subjects. The IBD-Q assesses the dimensions of bowel function, emotional status, systemic symptoms, and social function. Each of the 32 items is scored on a 1 to 7 scale, where higher scores represent a more positive response, and better outcome. The IBD-Q total score is calculated as the sum of all 32 items in the questionnaire, ranging from 32 to 224. | Baseline to Visit 10 (Day 56) or Early Termination |
| Change From Baseline in Total Number of Stools Daily | Subjects reported their daily stool frequency including loose and/or watery stools via a diary. The stool frequency including the number of loose and/or watery stools per day, equivalent to a score of a 6 or 7 on the Bristol Stool Scale, was recorded. Loose stools were described as fluffy pieces with ragged edges, a mushy stool. Watery stools were described as watery, no solid pieces. | Baseline to Visit 10 (Day 56) or Early Termination |
| Change From Baseline in Total Number of Loose/Watery Stools Daily | Subjects reported their daily assessment of stool frequency including loose and/or watery stools via a diary. The stool frequency including the number of loose and/or watery stools per day, equivalent to a score of a 6 or 7 on the Bristol Stool Scale, was recorded. Loose stools were described as fluffy pieces with ragged edges, a mushy stool. Watery stools were described as watery, no solid pieces. | Baseline to Visit 10 (Day 56) or Early Termination |
| Change From Baseline in Abdominal Pain | Subjects reported their daily assessment of abdominal pain via a diary. Abdominal pain was assessed on a scale of 0 to 3 with higher values indicating greater pain severity. | Baseline to Visit 10 (Day 56) or Early Termination |
| Change From Baseline in General Well-Being | Subjects reported their daily assessment of well-being via a diary. General well being was assessed on a scale of 0 to 4, with higher values indicating a poorer condition of health. | Baseline to Visit 10 (Day 56) or Early Termination |
| New Port Richey |
| Florida |
| 34653 |
| United States |
| Egleston Hospital | Atlanta | Georgia | 30322 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08900 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| The Center for Pediatric Inflammatory Bowel Disease, Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Clinical Associates in Research Therapeutics of America, LLC | San Antonio | Texas | 78212 | United States |
| Care Access Research | Salt Lake City | Utah | 84124 | United States |
| Safety Analysis Set |
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| Full Analysis Set |
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| PK Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | MDGN-002 1.0 mg/kg |
| BG001 | Cohort 2 | MDGN-002 3.0 mg/kg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | BMI not available for all subjects | Mean | Standard Deviation | kg/m2 |
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| Time Since Diagnosis (Years) | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) | The SES-CD is assessed through endoscopic review of 5 predefined gastrointestinal (GI) segments (ileum; right colon; transverse colon; left colon; rectum). For each segment, 4 endoscopic variables are assessed (presence of ulcers, ulcerated surface, affected surface, and presence of narrowing). Each variable is scored from 0 to 3 with higher scores indicating more severe symptoms. For each variable, the total score is calculated as the sum across all segments of the GI tract. The SES-CD total score, ranging from 0-60, is calculated as the sum of all variable total scores with a higher score indicating more severe endoscopic activity | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline to Visit 10 (Day 56) or early termination |
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| Secondary | Change From Baseline in Crohn's Disease Activity Index (CDAI) | The Crohn's Disease Activity Index (CDAI) consists of the following 8 items: abdominal pain, number of liquid stools, general well-being, extraintestinal complication, use of antidiarrheal drugs, abdominal mass, hematocrit, and body weight. Information on abdominal pain, general well-being, and frequency of loose and watery stools was taken from a daily diary completed by the subject. Total CDAI scores can range from 0 to approximately 600 with higher scores indicating more active disease. Disease severity as measured by CDAI is categorized as: Remission (<150), Mildly active disease (150 - 219); Moderately active disease (220 - 450); Severe disease (> 450). | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline to Visit 10 (Day 56) or early termination. |
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| Secondary | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q). | The IBD-Q is a 32-item questionnaire validated to measure quality of life in Crohn's disease subjects. The IBD-Q assesses the dimensions of bowel function, emotional status, systemic symptoms, and social function. Each of the 32 items is scored on a 1 to 7 scale, where higher scores represent a more positive response, and better outcome. The IBD-Q total score is calculated as the sum of all 32 items in the questionnaire, ranging from 32 to 224. | Full Analysis Set | Posted | Mean | Standard Deviation | score on a scale | Baseline to Visit 10 (Day 56) or Early Termination |
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| Secondary | Change From Baseline in Total Number of Stools Daily | Subjects reported their daily stool frequency including loose and/or watery stools via a diary. The stool frequency including the number of loose and/or watery stools per day, equivalent to a score of a 6 or 7 on the Bristol Stool Scale, was recorded. Loose stools were described as fluffy pieces with ragged edges, a mushy stool. Watery stools were described as watery, no solid pieces. | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | Posted | Mean | Standard Deviation | number of total daily stools | Baseline to Visit 10 (Day 56) or Early Termination |
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| Secondary | Change From Baseline in Total Number of Loose/Watery Stools Daily | Subjects reported their daily assessment of stool frequency including loose and/or watery stools via a diary. The stool frequency including the number of loose and/or watery stools per day, equivalent to a score of a 6 or 7 on the Bristol Stool Scale, was recorded. Loose stools were described as fluffy pieces with ragged edges, a mushy stool. Watery stools were described as watery, no solid pieces. | Full Analysis Set with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | Posted | Mean | Standard Deviation | number of daily loose/watery stools | Baseline to Visit 10 (Day 56) or Early Termination |
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| Secondary | Change From Baseline in Abdominal Pain | Subjects reported their daily assessment of abdominal pain via a diary. Abdominal pain was assessed on a scale of 0 to 3 with higher values indicating greater pain severity. | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline to Visit 10 (Day 56) or Early Termination |
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| Secondary | Change From Baseline in General Well-Being | Subjects reported their daily assessment of well-being via a diary. General well being was assessed on a scale of 0 to 4, with higher values indicating a poorer condition of health. | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline to Visit 10 (Day 56) or Early Termination |
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All adverse events were collected from the time of the informed consent until the final safety follow-up visit (Day 84 or 28 days after Early Termination). This included events occurring during the screening phase of the study, regardless of whether investigational product was administered. Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | MDGN-002 1.0 mg/kg | 0 | 4 | 1 | 4 | 2 | 4 |
| EG001 | Cohort 2 | MDGN-002 3.0 mg/kg | 0 | 4 | 1 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Gastroenteritis viral | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Body temperature increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Tunnel vision | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
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This was an open label study, exploratory in nature, without a placebo control group, and as such, limits the interpretation of the study data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Garry Neil, MD | Avalo Therapeutics, Inc. | 908-720-2691 | gneil@avalotx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2021 | Sep 7, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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