Ulcerative ColitisPhase 2TNFNCT03298022
Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC
A Phase 2 study testing ALTB-168 in people with Ulcerative Colitis, run by AltruBio Inc. at 12 sites in 2 countries.
Trial summary
To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- ALTB-168
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 4 May 2018to 1 Jun 2020
- Phase
- Phase 2
- 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
- Patients must provide written informed consent;
- Age 18-75 years;
- Diagnosis of UC ≥ 12 weeks prior to screening by full colonoscopy (i.e., ≥ 12 weeks after first diagnosis by a physician according to American College of Gastroenterology guidelines);
- Moderate-to-severe active UC, at time of screening, defined as:
- Mayo Clinic Score (MCS) of 6 points or higher, AND
- a centrally read MCS endoscopic subscore of grade 2 or higher, AND
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- MCS rectal bleeding subscore of 1 point or higher, AND
- disease extending 15 cm or more from the anal verge;
- Stable doses of concomitant medications, including :
- Stable oral corticosteroids (i.e., ≤ 20 mg/day of prednisone, ≤ 9 mg/day of budesonide) ≥ 2 weeks before D1 dosing; Taper of oral corticosteroids per Investigator's discretion during the study is allowed;
- Stable oral 5-amyinosalicylic acid dose ≥ 2 weeks before D1 dosing;
- Stable immunosuppressant including azathioprine, mercaptopurine, or methotrexate ≥ 8 weeks before D1 dosing. Patients taking methotrexate also are advised to take folic acid 1 mg/day or equivalent if there is no contraindication;
- Stable doses of probiotics ≥ 2 weeks before D1 dosing;
- Stable anti-diarrheas ≥ 2 weeks before D1 dosing;
- Patients must have previously received anti-tumor necrosis factor alpha (anti- TNF alpha and/or anti-integrin therapy for UC and demonstrated an inadequate response, loss of response, or intolerance, and must have discontinued therapy ≥ 8 weeks before D1 dosing;
- Patients previously treated with cyclosporine or tacrolimus must have discontinued therapy ≥ 4 weeks before D1 dosing;
- Topical corticosteroids and topical 5-amyinosalicylic acid preparations must have been withdrawn ≥ 2 weeks before D1 dosing;
- Nonsteroidal anti-inflammatory drugs (NSAIDs) must have been discontinued ≥ 4 weeks before D1 dosing;
- Tofacitinib or other Janus kinase (JAK) inhibitors must have been discontinued ≥ 2 weeks before D1 dosing;
- Patients previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 weeks before D1 dosing;
- Females with reproductive potential must have a negative pregnancy test result before enrollment. Men and women with reproductive potential have to be willing to use a highly effective method of contraception from study start to ≥ 3 months after the final dose of the study drug. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Who cannot join
- GI related exclusion criteria:
- Indeterminate colitis (Inflammatory bowel disease unclassified, IBD-U) or suspected Crohn's disease
- Any history of colectomy
- Presence of an ileostomy or colostomy
- A history or evidence of colonic mucosal dysplasia
- Short gut syndrome
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- General health related exclusion criteria:
- Pregnant or lactating
- Inability to comply with study protocol in the opinion of the investigator
- History of dysplasia or malignancy in recent 5 years, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Cirrhosis or active alcohol abuse per the judgement of investigator
- Poorly controlled diabetes (HbA1c > 8.0%)
- Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block
- Impaired renal function (calculated creatinine clearance < 60 mL/min)
- Impaired hepatic function in the absence of diagnosis of primary sclerosing cholangitis, serum transaminase > 2.5x Upper Limit Normal (ULN), alkaline phosphatase > 2.5x ULN, or increased total bilirubin judged by the investigator to be clinically significant, or a diagnosis of primary sclerosing cholangitis, serum transaminases > 3x ULN, alkaline phosphatase > 3x ULN, or total bilirubin > 2.5x ULN judged by the investigator to be clinically significant
- Moderate to severe anemia (Hb < 8g/dL)
- Thrombocytopenia (platelet count < 75,000/uL)
- Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the opinion of the investigator, would compromise the safety of the patient or quality of the data
- Requiring parenteral corticosteroid treatment.
- Received any investigational product within 1 year.
- History of drug abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria within 12 months prior to screening or positive drug screening tests.
- Infection related exclusion criteria:
- Human immune deficiency virus (HIV) infection or known HIV-related malignancy.
- Acute or chronic hepatitis B or C, or carrier status. Patients with anti-HBc Ab but with undetectable anti-HBs Ab should also be excluded.
- Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr virus
- Positive stool test for ova or parasites, positive stool culture for pathogens, or positive stool toxin assay for Clostridium difficile at screening. Patients with the positive stool toxin assay for C. difficile at screening could be rescreened if they are being treated for C. difficile and a repeat stool toxin assay at least 4 weeks after the completion of treatment is negative with no evidence of recurrence.
- Intestinal mucosa biopsy positive for cytomegalovirus (CMV) at screening.
- Positive screening test for latent Mycobacterium tuberculosis (TB) infection. Patients with a history of latent TB infection who received an appropriate and documented course of therapy can be included if the screening examination and a chest x-ray performed ≤ 3 months before screening revealed no evidence of current active infection. If a Quantiferon TB test is indeterminate, the test should be repeated, and if the result is again indeterminate, such patient should be excluded.
- History of any opportunistic infection ≤ 12 weeks before D1 dosing.
- Any current or recent (≤ 4 weeks before D1 dosing) symptoms/signs of infection.
- Received oral antibiotics ≤ 4 weeks before D1 dosing or intravenous antibiotics ≤ 8 weeks before D1 dosing.
- Received a live attenuated vaccine ≤ 4 weeks before D1 dosing.
- Neutropenia (absolute neutrophil count < 1,500/uL).
- Lymphocytopenia (absolute lymphocyte count < 500 /uL).
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Wellness Clinical Research (WCR)
Hialeah, Florida, 33016-2202
Baylor College of Medicine
Houston, Texas, 77030
Wellness Clinical Research (WCR)
Lake Wales, Florida, 33853
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
Weill Cornell Medical College
New York, New York, 10021
Stomach Doctor - Surinder Saini, MD - Fountain Valley
Newport Beach, California, 92660
University of Rochester Medical Center
Rochester, New York, 14642
Capitol Research
Rockville, Maryland, 20850
University of Washington Medical Center (UWMC) - Digestive Disease Center
Seattle, Washington, 98195
About this study
Official title: Efficacy and Safety of ALTB-168 in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis: a 26-week, Open-label, Multi-center, Phase II Proof of Principle Trial
To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.
Read the detailed description
This is a Phase II, open label, single arm, multiple dose proof of principle study to test the efficacy and safety of Neihulizumab in patients with moderate to severe active ulcerative colitis and who has failed or are intolerant to anti-TNFα and/or anti-integrin therapy. A minimum of 30 patients and a maximum of 40 will be recruited in 1 dosing group. For efficacy evaluation, the primary endpoint is the proportion of patients with clinical response, defined as ≥ 3- point reduction in MCS, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1 at Week 12. Safety assessments will consist of evaluating physical examination, vital signs (blood pressure, heart rate, respiratory rate, body temperature and oxygen saturation), safety laboratory tests, adverse events and tolerability.
- Conditions
- Ulcerative Colitis
- Being tested
- ALTB-168
- Keywords
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTB-168Biological
Also called Neihulizumab
monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| ALTB-168 | Experimental | intravenous doses of ALTB-168 Receives: Biological: ALTB-168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients With Clinical Response at Week 12
The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1,
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
Measured: week 12
Secondary outcomes (8)
The Proportion of Patients With Clinical Response (mITT)
The proportion of patients with clinical response defined as a ≥2-point decrease in partial MCS (pMCS), and with a 1 point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1.
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
Measured: weeks 6,16, 20 and 26
The Proportion of Patients With Clinical Remission
The number of patients with clinical remission, defined as MCS of 2 or lower (or pMCS of 1 or lower) and no subscore higher than 1.
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
Measured: weeks 6,16, 20 and 26
Flexible Sigmoidoscopy Subscore Changes From Baseline
The mean (SD) observed flexible sigmoidoscopy subscore change from baseline (CFB).
Baseline is defined as the last available assessment prior to the first administration of the study drug. The sigmoidoscopic improvement is defined as any decrease in Mayo Clinic Score (MCS) endoscopic subscore, at Weeks 12 and 26. MCS range is 1-3.
The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
Measured: Baseline, week 12- and week 26 after the first treatment
The Number of Patients With Mucosal Healing
The mucosal healing is defined as an absolute subscore for endoscopy of 0 or 1 The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points).
Lower score means disease improvement.
Measured: at 12- and 26-week after the first treatment
Change of Histological Activity Grade From Baseline Using the Geboes System
The number of patients with histological activity Geboes Score ≤ 3.1 (worst of both rectum and sigmoid colon).
The original Geboes grade system is from Grade 0 to Grade 5.
The following are the grades:
Grade 0: Architectural changes Grade 1: Chronic inflammatory infiltrate Grade 2A: Eosinophils in lamina propria Grade 2B: Neutrophils in lamina propria Grade 3: Neutrophils in epithelium Grade 4:Crypt destruction Grade 5: Erosions and ulcerations
Measured: at 12- and 26-week after the first treatment
The Number of Patients With Histological Healing
The histological healing is defined as histological grade = 0
Measured: at 12- and 26-week after the first treatment
Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
Number of Participants with a Clinically Significant Difference in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline, to Week 12 and Week 26.
The IBDQ is a questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in patients with the Inflammatory Bowel Disease (IBD). The IBDQ has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better HRQoL. A difference of 16 points from Baseline Assessment (Baseline Score) to Week 12, and Baseline Assessment (Baseline Score) to Week 26, is considered clinically significant. The outcome measure is assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26. Patients who achieved the 16 point difference (improvement of the IBDQ score from the baseline indicating the Clinically Significant Difference) are included as responders to the treatment.
Measured: at 12- and 26-week after the first treatment
The Number of Patients With Inflammatory IBDQ Response
The Inflammatory Bowel Disease Questionnaire (IBDQ) has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better Health Related Quality of Life (HRQoL). A difference of 16 points from Baseline to Week 12 and Baseline to Week 26, is considered clinically significant. The outcome measure will be assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26, to assess whether a response was seen.
Measured: at 12- and 26-week after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start4 May 2018
- Primary completion6 Apr 2020
- Study completion1 Jun 2020
Why it stopped: As a consequence of operational difficulties at the clinical sites associated with the COVID-19 pandemic
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 Ulcerative ColitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AltruBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shih-Yao Lin, MD, PhD, Study director, AltruBio Inc.David T Rubin, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298022
- Sponsor's protocol ID
- 2017.008.01
- Acronym
- TNF
- Status last verified
- Jan 2024
- First submitted
- 27 Sep 2017
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of ALTB-168 in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis: a 26-week, Open-label, Multi-center, Phase II Proof of Principle Trial
- ClinicalTrials.gov ID
- NCT03298022
- Acronym / sponsor ID
- TNF / 2017.008.01
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As a consequence of operational difficulties at the clinical sites associated with the COVID-19 pandemic
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AltruBio Inc.Industry (pharma, biotech, devices)
- Study start
- 4 May 2018 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Posted 6 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.
Detailed description
This is a Phase II, open label, single arm, multiple dose proof of principle study to test the efficacy and safety of Neihulizumab in patients with moderate to severe active ulcerative colitis and who has failed or are intolerant to anti-TNFα and/or anti-integrin therapy. A minimum of 30 patients and a maximum of 40 will be recruited in 1 dosing group. For efficacy evaluation, the primary endpoint is the proportion of patients with clinical response, defined as ≥ 3- point reduction in MCS, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1 at Week 12. Safety assessments will consist of evaluating physical examination, vital signs (blood pressure, heart rate, respiratory rate, body temperature and oxygen saturation), safety laboratory tests, adverse events and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALTB-168 | Experimental | Biological: ALTB-168intravenous doses of ALTB-168 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must provide written informed consent;
- Age 18-75 years;
- Diagnosis of UC ≥ 12 weeks prior to screening by full colonoscopy (i.e., ≥ 12 weeks after first diagnosis by a physician according to American College of Gastroenterology guidelines);
- Moderate-to-severe active UC, at time of screening, defined as:
- Stable doses of concomitant medications, including :
Key exclusion criteria (34 listed)
- Indeterminate colitis (Inflammatory bowel disease unclassified, IBD-U) or suspected Crohn's disease
- Any history of colectomy
- Presence of an ileostomy or colostomy
- A history or evidence of colonic mucosal dysplasia
- Short gut syndrome
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 |
|---|---|---|
| ALTB-168Also: Neihulizumabmonoclonal antibody | Biological | ALTB-168 |
Primary outcome
The Proportion of Patients With Clinical Response at Week 12
Time frame: week 12
The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1, The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
8 secondary outcomes
The Proportion of Patients With Clinical Response (mITT)
Time frame: weeks 6,16, 20 and 26
The Proportion of Patients With Clinical Remission
Time frame: weeks 6,16, 20 and 26
Flexible Sigmoidoscopy Subscore Changes From Baseline
Time frame: Baseline, week 12- and week 26 after the first treatment
The Number of Patients With Mucosal Healing
Time frame: at 12- and 26-week after the first treatment
Change of Histological Activity Grade From Baseline Using the Geboes System
Time frame: at 12- and 26-week after the first treatment
The Number of Patients With Histological Healing
Time frame: at 12- and 26-week after the first treatment
Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
Time frame: at 12- and 26-week after the first treatment
The Number of Patients With Inflammatory IBDQ Response
Time frame: at 12- and 26-week after the first treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Shih-Yao Lin, MD, PhD study director
AltruBio Inc.
David T Rubin, MD principal investigator
University of Chicago
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALTB-168 in people with Ulcerative Colitis, run by AltruBio Inc. at 12 sites in 2 countries.
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 21 inclusion and 34 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 6 Jul 2023). 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?
The Proportion of Patients With Clinical Response at Week 12 (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.