Back to resultsEfficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC (TNF)
Primary Purpose
Ulcerative Colitis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALTB-168
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- 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
- 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-aminosalicylic 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- Topical corticosteroids and topical 5-amyinosalicylic acid preparations must have been withdrawn ≥ 2 weeks before D1 dosing;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).
Exclusion Criteria:
- GI related exclusion criteria:
- Indeterminate colitis (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
-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).
Sites / Locations
- Lynn Institute of the Ozarks
- Stomach Doctor - Surinder Saini, MD - Fountain Valley
- Wellness Clinical Research (WCR)
- Wellness Clinical Research (WCR)
- Northwestern University Feinberg School of Medicine
- University of Chicago
- Capitol Research
- Weill Cornell Medical College
- University of Rochester Medical Center
- Baylor College of Medicine
- University of Washington Medical Center (UWMC) - Digestive Disease Center
- Wellness Clinical Research (WCR)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALTB-168
Arm Description
intravenous doses of ALTB-168
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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
The Number of Patients With Histological Healing
The histological healing is defined as histological grade = 0
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03298022
Brief Title
Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC
Acronym
TNF
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
As a consequence of operational difficulties at the clinical sites associated with the COVID-19 pandemic
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
April 6, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AltruBio Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALTB-168
Arm Type
Experimental
Arm Description
intravenous doses of ALTB-168
Intervention Type
Biological
Intervention Name(s)
ALTB-168
Other Intervention Name(s)
Neihulizumab
Intervention Description
monoclonal antibody
Primary Outcome Measure Information:
Title
The Proportion of Patients With Clinical Response at Week 12
Description
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.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
The Proportion of Patients With Clinical Response (mITT)
Description
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.
Time Frame
weeks 6,16, 20 and 26
Title
The Proportion of Patients With Clinical Remission
Description
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.
Time Frame
weeks 6,16, 20 and 26
Title
Flexible Sigmoidoscopy Subscore Changes From Baseline
Description
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.
Time Frame
Baseline, week 12- and week 26 after the first treatment
Title
The Number of Patients With Mucosal Healing
Description
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.
Time Frame
at 12- and 26-week after the first treatment
Title
Change of Histological Activity Grade From Baseline Using the Geboes System
Description
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
Time Frame
at 12- and 26-week after the first treatment
Title
The Number of Patients With Histological Healing
Description
The histological healing is defined as histological grade = 0
Time Frame
at 12- and 26-week after the first treatment
Title
Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
Description
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.
Time Frame
at 12- and 26-week after the first treatment
Title
The Number of Patients With Inflammatory IBDQ Response
Description
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.
Time Frame
at 12- and 26-week after the first treatment
Other Pre-specified Outcome Measures:
Title
CRP Changes From Baseline (CFB) (Exploratory)
Description
Change in biomarkers of CRP (C-reactive protein). C-reactive protein (CRP) is a biomarker produced by your liver in response to inflammation. Normal CRP value is below 1 mg/L.
1-3 mg/L is in the "yellow zone", indicating some inflammation >3 mg/L is in the "red zone", meaning there is significant inflammation
Time Frame
Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26
Title
Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
Description
Faecal calprotectin changes from the baseline at Week 4, 9, 12, 16, 20, and 26 were measured. Baseline is defined as the last available assessment prior to the first administration of the study drug.
Faecal calprotectin is measured as mcg/g, so the results come back as a numeric value. A level under 50 is considered to be 'normal'. A level between 50 and 100, coupled with digestive symptoms, means IBS is likely. Lower level means improvement.
Time Frame
Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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-aminosalicylic 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).
Exclusion Criteria:
- GI related exclusion criteria:
Indeterminate colitis (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
-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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Yao Lin, MD, PhD
Organizational Affiliation
AltruBio Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David T Rubin, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Stomach Doctor - Surinder Saini, MD - Fountain Valley
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Wellness Clinical Research (WCR)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-2202
Country
United States
Facility Name
Wellness Clinical Research (WCR)
City
Lake Wales
State/Province
Florida
ZIP/Postal Code
33853
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Capitol Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington Medical Center (UWMC) - Digestive Disease Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Wellness Clinical Research (WCR)
City
Vega Baja
ZIP/Postal Code
00694
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC
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