Trial · NCT03169894
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
NCT03169894, Phase 1, Terminated, Avalo Therapeutics, Inc.; results first posted 2024-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis. Trials, record NCT03169894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03169894
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
- NCT number
- NCT03169894
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- Avalo Therapeutics, Inc.
- Conditions
- Crohn Disease, Ulcerative Colitis
- Interventions
- MDGN-002
- First posted
- 2017-05-30
- Last updated
- 2024-02-26
- Results first posted
- 2024-02-26
- Limitations and caveats
- This was an open label study, exploratory in nature, without a placebo control group, and as such, limits the interpretation of the study data.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) | Baseline to Visit 10 (Day 56) or early termination | 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 |
| Secondary | Change From Baseline in Crohn's Disease Activity Index (CDAI) | Baseline to Visit 10 (Day 56) or early termination. | 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). |
| Secondary | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q). | Baseline to Visit 10 (Day 56) or Early Termination | 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. |
| Secondary | Change From Baseline in Total Number of Stools Daily | Baseline to Visit 10 (Day 56) or Early Termination | 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. |
| Secondary | Change From Baseline in Total Number of Loose/Watery Stools Daily | Baseline to Visit 10 (Day 56) or Early Termination | 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. |
| Secondary | Change From Baseline in Abdominal Pain | Baseline to Visit 10 (Day 56) or Early Termination | 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. |
| Secondary | Change From Baseline in General Well-Being | Baseline to Visit 10 (Day 56) or Early Termination | 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. |
Source ClinicalTrials.gov
Outcomes7
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 Simple Endoscopic Score for Crohn's Disease (SES-CD) | Baseline to Visit 10 (Day 56) or early termination | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Crohn's Disease Activity Index (CDAI) | Baseline to Visit 10 (Day 56) or early termination. | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q). | Baseline to Visit 10 (Day 56) or Early Termination | Full Analysis Set | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Number of Stools Daily | Baseline to Visit 10 (Day 56) or Early Termination | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | number of total daily stools | MEAN |
| SECONDARY | Change From Baseline in Total Number of Loose/Watery Stools Daily | Baseline to Visit 10 (Day 56) or Early Termination | Full Analysis Set with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | number of daily loose/watery stools | MEAN |
| SECONDARY | Change From Baseline in Abdominal Pain | Baseline to Visit 10 (Day 56) or Early Termination | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | score on a scale | MEAN |
| SECONDARY | Change From Baseline in General Well-Being | Baseline to Visit 10 (Day 56) or Early Termination | Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) | Cohort 1 | -4.0 | Standard Deviation 4.36 | score on a scale | |
| Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) | Cohort 2 | 1.3 | Standard Deviation 7.50 | score on a scale | |
| Change From Baseline in Crohn's Disease Activity Index (CDAI) | Cohort 1 | -19.2 | Standard Deviation 38.34 | score on a scale | |
| Change From Baseline in Crohn's Disease Activity Index (CDAI) | Cohort 2 | -123.6 | Standard Deviation NA | score on a scale | |
| Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q). | Cohort 1 | 43.5 | Standard Deviation 29.01 | score on a scale | |
| Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q). | Cohort 2 | 47.0 | Standard Deviation 31.59 | score on a scale | |
| Change From Baseline in Total Number of Stools Daily | Cohort 1 | 1.37 | Standard Deviation 0.286 | number of total daily stools | |
| Change From Baseline in Total Number of Stools Daily | Cohort 2 | -0.99 | Standard Deviation 4.462 | number of total daily stools | |
| Change From Baseline in Total Number of Loose/Watery Stools Daily | Cohort 1 | 0.90 | Standard Deviation 1.077 | number of daily loose/watery stools | |
| Change From Baseline in Total Number of Loose/Watery Stools Daily | Cohort 2 | -1.07 | Standard Deviation 5.758 | number of daily loose/watery stools |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 4 | |
| Overall Study | STARTED | Cohort 2 | 4 | |
| Overall Study | Safety Analysis Set | Cohort 1 | 4 | |
| Overall Study | Safety Analysis Set | Cohort 2 | 4 | |
| Overall Study | Full Analysis Set | Cohort 1 | 4 | |
| Overall Study | Full Analysis Set | Cohort 2 | 4 | |
| Overall Study | PK Analysis Set | Cohort 1 | 4 | |
| Overall Study | PK Analysis Set | Cohort 2 | 3 | |
| Overall Study | COMPLETED | Cohort 1 | 4 | |
| Overall Study | COMPLETED | Cohort 2 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events56
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 | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 | 1 | 4 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2 | 0 | 4 | 0 |
| other | Gastroenteritis viral | Gastrointestinal disorders | Cohort 1 | 1 | 4 | 1 |
| other | Gastroenteritis viral | Gastrointestinal disorders | Cohort 2 | 0 | 4 | 0 |
| other | Nasopharyngitis | Infections and infestations | Cohort 1 | 1 | 4 | 1 |
| other | Nasopharyngitis | Infections and infestations | Cohort 2 | 0 | 4 | 0 |
| other | Sinusitis | Infections and infestations | Cohort 1 | 1 | 4 | 1 |
| other | Sinusitis | Infections and infestations | Cohort 2 | 0 | 4 | 0 |
| other | Contusion | Injury, poisoning and procedural complications | Cohort 1 | 1 | 4 | 1 |
| other | Contusion | Injury, poisoning and procedural complications | Cohort 2 | 0 | 4 | 0 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 4 |
| Total, all-cause mortality | Cohort 2 | 0 | 4 |
| Total, other adverse events | Cohort 1 | 2 | 4 |
| Total, other adverse events | Cohort 2 | 3 | 4 |
| Total, serious adverse events | Cohort 1 | 1 | 4 |
| Total, serious adverse events | Cohort 2 | 1 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: 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.
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/NCT03169894
GET https://conductscience.org/api/trials/v1/NCT03169894/events?page=2