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As a consequence of operational difficulties at the clinical sites associated with the COVID-19 pandemic
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTB-168 | Experimental | intravenous doses of ALTB-168 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTB-168 | Biological | monoclonal antibody |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CRP Changes From Baseline (CFB) (Exploratory) | 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 | Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26 |
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:
Stable doses of concomitant medications, including :
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 (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
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).
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| Name | Affiliation | Role |
|---|---|---|
| Shih-Yao Lin, MD, PhD | AltruBio Inc. | Study Director |
| David T Rubin, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72205 | United States | ||
| Stomach Doctor - Surinder Saini, MD - Fountain Valley |
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Participants were enrolled at 12 centers locate in North America and Puerto Rico from May 2018 to June 2020. It was a 24 weeks open label, single arm, multiple dose proof of principle study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALTB-168 in Patients With Refractory Ulcerative Colitis | Amendment 1~3: 9 mg/kg; total of 8 doses of ALTB-168. Amendment 4: 9 mg/kg; total of 10 doses of ALTB-168. |
| 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 | Nov 6, 2018 | Feb 28, 2023 |
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| 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. | 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. | 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. | 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 | 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 | 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. | 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. | at 12- and 26-week after the first treatment |
| Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker | 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. | Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26 |
| Newport Beach |
| California |
| 92660 |
| United States |
| Wellness Clinical Research (WCR) | Hialeah | Florida | 33016-2202 | United States |
| Wellness Clinical Research (WCR) | Lake Wales | Florida | 33853 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Capitol Research | Rockville | Maryland | 20850 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Washington Medical Center (UWMC) - Digestive Disease Center | Seattle | Washington | 98195 | United States |
| Wellness Clinical Research (WCR) | Vega Baja | 00694 | Puerto Rico |
| Number of Participants Who Received 8 Doses of ALTB-168 |
|
| Number of Participants Who Received 10 Doses of ALTB-168 |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Safety population /The mITT set was defined as all patients who were enrolled and who received at least one dose of ALTB-168 treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | ALTB-168 | Intravenous doses of ALTB-168 ALTB-168: monoclonal antibody |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Total enrolled number of participants is 24. 10 participants were enrolled under Amendment 1-3 14 participants were enrolled under Amendment 4 | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | 10 subjects were enrolled under Amendment 1-3 and 14 subjects under Amendment 4. | Median | Full Range | years |
| ||||||||||||||||
| Sex: Female, Male | Row population does not differ from the Overall population. Altogether 24 participants were enrolled to the study. Out of them 10 were enrolled under protocol Amendments 1-3 and 14 under the Amendment 14. | Count of Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | 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. | The full analysis set includes all participants who received at least 1 dose of study drug. The response rates were calculated using non-responder imputation, where participants with a missing scores at week 12 were counted as non-responders. | Posted | Number | 95% Confidence Interval | percentage of total number of patients | week 12 |
|
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| ||||||||||||||||||||||||||||
| Secondary | 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 full analysis set includes all participants who received at least 1 dose of study drug. Response rates were calculated using non-responder imputation, where participants with a missing information were counted as non-responders. 23 participants are included in the study analysis. 9 participants from the pilot study (protocol Amendments 1-3) and 14 participants from the main study (protocol Amendment 4). | Posted | Number | 95% Confidence Interval | percentage of total number of patients | weeks 6,16, 20 and 26 |
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| Secondary | 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. | The full analysis set includes all participants who received at least 1 dose of study drug. Response rates were calculated using non-responder imputation, where participants with a missing information were counted as non-responders. 23 participants are included in the study analysis. 9 participants from the pilot study (protocol Amendments 1-3) and 14 participants from the main study (protocol Amendment 4). | Posted | Number | 95% Confidence Interval | percentage of total number of patients | weeks 6,16, 20 and 26 |
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| Secondary | 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. | Study participants who entered the study under amendment 1-3 (n=9) and participans who entered the study under amendment 4 (n=14) have been inlcuded in this analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12- and week 26 after the first treatment |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 2 missing; Week 26 - 7 missing). | Posted | Number | participants | at 12- and 26-week after the first treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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 | Study participants who received at least one dose of ALTB-168 | Posted | Number | participants | at 12- and 26-week after the first treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Number of Patients With Histological Healing | The histological healing is defined as histological grade = 0 | Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 4 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 2 missing; Week 26 - 7 missing). | Posted | Count of Participants | Participants | at 12- and 26-week after the first treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 0 missing; Week 26 - 6 missing). | Posted | Number | participants | at 12- and 26-week after the first treatment |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 0 missing; Week 26 - 6 missing). | Posted | Number | participants | at 12- and 26-week after the first treatment |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | CRP Changes From Baseline (CFB) (Exploratory) | 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 | Study participants who received at least one dose of ALTB-168 | Posted | Mean | Standard Deviation | mg/L | Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26 |
|
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| Other Pre-specified | Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker | 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. | Study participants who received at least one dose of ALTB-168 | Posted | Mean | Standard Deviation | mcg/g | Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26 |
|
|
26 weeks
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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 | ALTB-168 9mg/kg (Amendment 1-3) | Amendments 1-3: A total of 8 doses of ALTB-168 at 9 mg/kg | 0 | 10 | 1 | 10 | 9 | 10 |
| EG001 | ALTB-168 9mg/kg (Amendment 4) | Amendment 4: A total of 10 doses of ALTB-168 at 9 mg/kg | 0 | 14 | 0 | 14 | 13 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative Colitis Flare | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Participant ID AE Term Date of onset AE Outcome Relatedness to IP 1010003 Ulcerative Colitis flare 05AUG2018 Resolved Not related |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Confusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Fecal Calprotectin Increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Palate Injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Lymphocyte Count Decreased | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Ear Swelling | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Oral Pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Tongue Ulceration | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Body Tinea | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Clinical Operations | AltruBio | 17142150224 | simona.reed@altrubio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2020 | Mar 6, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2017 | Mar 6, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| >=65 years |
|
| Enrolled Under Amendment 4 |
|
|
| Amendment 4 |
|
|
| Male |
|
| Enrolled under Amendment 4 |
|
|
|
| Not reported |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
Amendment 4: 9 mg/kg; total 10 doses of ALTB-168
|
|
|
|
|
|