Crohn DiseasePhase 1NCT03169894

Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis

A Phase 1 study testing MDGN-002 in people with Crohn Disease and Ulcerative Colitis, run by Avalo Therapeutics, Inc. at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Crohn Disease, Ulcerative Colitis
What is being tested?: MDGN-002
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 13 sitesUnited States
Study dates: 14 Jul 2017to 12 Oct 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is male or female, ≥ 18 to ≤ 75 years of age.
Subject has a documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation, or subject has received a diagnosis of UC for 90 days or greater prior to Visit 1, confirmed by endoscopy during the Screening Period, with exclusion of current infection, dysplasia and/or malignancy.
Subject has moderate to severe, active CD as evidenced Simple Endoscopy Score for Crohn's Disease (SES-CD) score of ≥7, and histological confirmation, or subject has moderately to severely active UC, as defined by a Modified Mayo Score (excluding the PGA component) of 5 to 9 points at Visit 1.
Subject has failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment.

Who cannot join

Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis or subject has a diagnosis of Crohn's disease or indeterminate colitis .
Subject with signs or symptoms of bowel obstruction.
Subject has short bowel syndrome.
Subject has a current functional colostomy or ileostomy.
Subject has had a surgical bowel resection within the past 6 months prior to screening or is planning any resection during the study period.
Subject is pregnant or a nursing mother.
Subject is sexually active and not using effective contraception as defined in the protocol.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Egleston Hospital
Atlanta, Georgia, 30322
Hassman Research Institute
Berlin, New Jersey, 08900
University of Cincinnati
Cincinnati, Ohio, 45267
Sweet Hope Research Specialty, Inc.
Hialeah, Florida, 33016
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Louisville
Louisville, Kentucky, 40202
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Advanced Research Institute, Inc.
New Port Richey, Florida, 34653
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
The Center for Pediatric Inflammatory Bowel Disease, Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Care Access Research
Salt Lake City, Utah, 84124
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas, 78212

Other trials in United States

About this study

Official title: Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis Who Previously Failed Treatment With an Anti-TNFα Agent

Conditions: Crohn Disease, Ulcerative Colitis
Being tested: MDGN-002
Medical subject headings: Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MDGN-002Drug
Also called AVTX-002, AEVI-002
MDGN-002 is a fully human IgG4 monoclonal antibody specific to human LIGHT.

Study groups in NCT03169894
Study group	Role	What they receive
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. Receives: Drug: MDGN-002

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline to Visit 10 (Day 56) or early termination

Secondary outcomes (6)

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Visit 10 (Day 56) or Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 201712 Oct 2021

First posted30 May 2017
Study start14 Jul 2017
Primary completion14 Sep 2021
Study completion12 Oct 2021

Why it stopped: Strategic reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Crohn DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03169894
Sponsor's protocol ID: MDGN-002-CD-101
Status last verified: Jul 2023
First submitted: 24 May 2017
Last updated: 26 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Crohn Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis Who Previously Failed Treatment With an Anti-TNFα Agent
ClinicalTrials.gov ID: NCT03169894
Acronym / sponsor ID: MDGN-002-CD-101
Conditions: Crohn Disease, Ulcerative Colitis
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic reasons
Enrolment: 8 participants (actual)
Lead sponsor: Avalo Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 14 Jul 2017 (actual)
Primary completion: 14 Sep 2021 (actual)
Study completion: 12 Oct 2021 (actual)
First posted: 30 May 2017 (actual)
Results: Posted 26 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MDGN-002	Experimental	Drug: MDGN-002MDGN-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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject is male or female, ≥ 18 to ≤ 75 years of age.
Subject has a documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation, or subject has received a diagnosis of UC for 90 days or greater prior to Visit 1, confirmed by endoscopy during the Screening Period, with exclusion of current infection, dysplasia and/or malignancy.
Subject has moderate to severe, active CD as evidenced Simple Endoscopy Score for Crohn's Disease (SES-CD) score of ≥7, and histological confirmation, or subject has moderately to severely active UC, as defined by a Modified Mayo Score (excluding the PGA component) of 5 to 9 points at Visit 1.
Subject has failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment.

Key exclusion criteria (7 listed)

Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis or subject has a diagnosis of Crohn's disease or indeterminate colitis .
Subject with signs or symptoms of bowel obstruction.
Subject has short bowel syndrome.
Subject has a current functional colostomy or ileostomy.
Subject has had a surgical bowel resection within the past 6 months prior to screening or is planning any resection during the study period.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MDGN-002Also: AVTX-002, AEVI-002MDGN-002 is a fully human IgG4 monoclonal antibody specific to human LIGHT.	Drug	MDGN-002

Primary outcome

Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: 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

6 secondary outcomes

Change From Baseline in Crohn's Disease Activity Index (CDAI)
Time frame: Baseline to Visit 10 (Day 56) or early termination.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q).
Time frame: Baseline to Visit 10 (Day 56) or Early Termination
Change From Baseline in Total Number of Stools Daily
Time frame: Baseline to Visit 10 (Day 56) or Early Termination
Change From Baseline in Total Number of Loose/Watery Stools Daily
Time frame: Baseline to Visit 10 (Day 56) or Early Termination
Change From Baseline in Abdominal Pain
Time frame: Baseline to Visit 10 (Day 56) or Early Termination
Change From Baseline in General Well-Being
Time frame: Baseline to Visit 10 (Day 56) or Early Termination

Results and safety

Results posted to the registry on 26 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	4	4
Cohort 2	4	4

Primary outcome: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)

Time frame: Baseline to Visit 10 (Day 56) or early termination. Mean (Standard Deviation). Unit: score on a scale

Measure	Cohort 1 n = 3	Cohort 2 n = 4
Value	-4.0 (4.36)	1.3 (7.50)

Population analysed: Full Analysis Set, with data analyzed and presented only for subjects with both a Baseline and Visit 10 or Early Termination assessment

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	1 of 4 (25%)	2 of 4 (50%)	0 of 4
Cohort 2	1 of 4 (25%)	3 of 4 (75%)	0 of 4

Limitations and caveats (from the sponsor): This was an open label study, exploratory in nature, without a placebo control group, and as such, limits the interpretation of the study data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Crohn Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDGN-002 in people with Crohn Disease and Ulcerative Colitis, run by Avalo Therapeutics, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) (time frame: Baseline to Visit 10 (Day 56) or early termination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03169894.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.