ACTIVE_NOT_RECRUITING

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase, a Maintenance Phase, and an OLE.

Official Title

Phase 2a, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of ALTB-268 in Subjects With Moderately to Severely Active Ulcerative Colitis Refractory to Biologic Therapy

Quick Facts

Study Start:2023-12-04

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06109441

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adult participants 18 to 75 years old, inclusive, at Screening. 2. Willing to provide informed consent and to be compliant with the schedule of study visits and protocol assessments. 3. Diagnosis of UC established at least 12 weeks prior to Screening by standard clinical and endoscopic evidence and corroborated by a histopathology report. 4. Moderately to severely active UC, at the time of Screening, defined as a modified Mayo Score (mMS) of 5-9, inclusive, with an endoscopic subscore of ≥ 2 (from central reading), and a rectal bleeding (RB) subscore of ≥ 1. 5. Evidence of active UC, extending proximal to the rectum with ≥ 15 cm of involved colon. 6. Stable doses of concomitant medications: 1. Subjects receiving oral corticosteroids for the treatment of UC must be on a stable dose of ≤ 20 mg/day (prednisone or equivalent), or ≤ 9 mg/day budesonide. This dose must be stable from the initial Screening visit until the end of the Induction Phase. 2. Subjects receiving oral 5-aminosalicylic acid (5-ASA) must be on a stable dose from the initial Screening visit until the end of study. 3. Subjects receiving immunosuppressants (azathioprine, 6-mercaptopurine \[6-MP\] or methotrexate) must be on a stable dose for 4 weeks prior to Screening until the end of study treatment. Subjects taking methotrexate are also advised to take folic acid 5 mg/week (or equivalent) if there is no contraindication. 4. Subjects receiving probiotics must be on a stable dose from the initial Screening visit until the end of study. 5. Subjects receiving an anti-diarrhetic must be on a stable dose for ≥ 2 weeks prior to Screening until the end of study. 7. Previous treatment with one or two advanced therapy that demonstrated an inadequate response and/or loss of response. 8. Negative pregnancy test during Screening and Day 1 (V0) in females of childbearing potential. 9. Females with reproductive potential must be sexually abstinent or be willing to use a highly effective method of contraception from study start to ≥ 3 months after the final dose of the study drug. Highly effective methods of contraception include: 1. Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); male partner should use a condom; 2. Intrauterine device or system; or 3. Surgical sterilization or partner sterile (must have documented proof). 10. Male subjects must be either surgically sterile (must have documented proof), agree to be sexually abstinent, or use a double-barrier method of birth control (e.g., condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration to ≥ 3 months after the final dose administration. 11. Male subjects must agree to refrain from donating sperm from first study drug administration to ≥ 3 months after final dose administration.	1. Diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID)-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC), or radiation-induced colitis. 2. Ulcerative colitis limited to the rectum (ulcerative proctitis). 3. Presence of short bowel syndrome. 4. History of colectomy, or presence of an ileostomy or colostomy. 5. History of, or active colonic mucosal dysplasia. 6. Treatment with any intravenous (IV) corticosteroid or rectal therapy during the Screening period. 7. Treatment with any calcineurin inhibitor (e.g., cyclosporine, tacrolimus) from the initial Screening visit. 8. Treatment with NSAIDs within 4 weeks prior to Screening. Short-term use (\<7 days) of NSAIDs for non-UC related symptoms is allowed. 9. Treatment with tofacitinib or other Janus Kinase (JAK) inhibitors from the initial Screening visit. 10. Treatment with sphingosine-1-phosphate receptor (S1PR) modulators from the initial Screening visit. 11. Biologic therapy within 56 days or 5 half-lives (whichever is longer) prior to Screening. Confirmation of undetectable or non-therapeutic serum levels, as assessed by the Investigator, will allow for eligibility. 12. Tube feeding, defined formula diets, or parenteral alimentation/nutrition within 3 weeks of first dosing. 13. Treatment with oral antibiotics within 4 weeks prior to Screening or IV antibiotics within 8 weeks prior to Screening. 14. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to Screening. 15. History of dysplasia or malignancy in the past 5 years, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. 16. Subjects with a current or recent history of severe, progressive, or uncontrolled cardiac (including uncontrolled hypertension), renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological (e.g., history of seizures) disease, or any other severe comorbidity that, in the opinion of the Investigator, could confound the study results or put the subject at unreasonable risk. 17. Significant screening electrocardiogram (ECG) abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block. 18. For males, a QTc interval (Fridericia's correction) of \>450 ms, and for females, a QTc interval (Fridericia's correction) of \>470 ms. 19. Any of following laboratory abnormalities during the Screening period. If values are initially outside prescribed limits, the evaluation may be repeated once within the Screening period to determine eligibility: 1. Calculated creatinine clearance \< 60 mL/min 2. Serum transaminases \> 2.0x Upper Limit Normal (ULN) 3. Alkaline phosphatase (ALP) \> 2.0x ULN 4. Bilirubin \> 1.5x ULN; does not apply to subjects with Gilbert's Syndrome (Meulengracht Syndrome) 5. Hemoglobin \< 8g/dL 6. Platelets \< 75,000/μL 7. Absolute neutrophil count \< 1,500/ μL 8. Absolute lymphocyte count \< 800/ μL 20. Human immune deficiency virus (HIV) infection or known HIV-related malignancy. 21. Acute or chronic hepatitis B (HBV) or hepatitis C (HCV), or carrier status. Subjects with anti-HBc (hepatitis B core) antibodies (Ab) but with undetectable anti-HBs (hepatitis B surface) Ab should be excluded. 22. Positive immunoglobulin M (IgM) Ab titers in the presence of negative immunoglobulin G (IgG) Ab titers to Epstein-Barr virus (EBV). 23. Positive stool test for ova or parasites, positive stool culture for pathogens, or positive stool toxin assay for Clostridium difficile at Screening. 24. Active cytomegalovirus (CMV) infection at Screening, as assessed by the Investigator. 25. Positive QuantiFERON® TB test at Screening for latent Mycobacterium tuberculosis (TB) infection. If a QuantiFERON® TB test is indeterminate, the test should be repeated. If the result is again indeterminate, the subject should be excluded. 26. History of any opportunistic infection within 12 weeks of first dosing. 27. Any current or recent symptoms/signs of infection, except nasopharyngitis, within 4 weeks of first dosing. 28. Cirrhosis or active alcohol abuse, pr the judgment of the Investigator. 29. History of drug abuse according teo the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria within 12 months prior to Screening or a positive drug screening test. 30. Currently breast feeding, or pregnant. 31. Known hypersensitivity or intolerance to ALTB-268 or any of its excipients. 32. Participation in another clinical trial AND having received investigational medication within 30 days or 5 half-lives (whichever is longer) prior to Screening or having used an investigational device treatment within 30 days prior to Screening. Concurrent participation in an observational or long-term follow-up study and not actively receiving an investigational drug or device treatment may be eligible for participation in this study. 33. Inability to comply with the study protocol, in the opinion of the Investigator.

Inclusion Criteria

Exclusion Criteria

1. Adult participants 18 to 75 years old, inclusive, at Screening.
2. Willing to provide informed consent and to be compliant with the schedule of study visits and protocol assessments.
3. Diagnosis of UC established at least 12 weeks prior to Screening by standard clinical and endoscopic evidence and corroborated by a histopathology report.
4. Moderately to severely active UC, at the time of Screening, defined as a modified Mayo Score (mMS) of 5-9, inclusive, with an endoscopic subscore of ≥ 2 (from central reading), and a rectal bleeding (RB) subscore of ≥ 1.
5. Evidence of active UC, extending proximal to the rectum with ≥ 15 cm of involved colon.
6. Stable doses of concomitant medications:
1. Subjects receiving oral corticosteroids for the treatment of UC must be on a stable dose of ≤ 20 mg/day (prednisone or equivalent), or ≤ 9 mg/day budesonide. This dose must be stable from the initial Screening visit until the end of the Induction Phase.
2. Subjects receiving oral 5-aminosalicylic acid (5-ASA) must be on a stable dose from the initial Screening visit until the end of study.
3. Subjects receiving immunosuppressants (azathioprine, 6-mercaptopurine \[6-MP\] or methotrexate) must be on a stable dose for 4 weeks prior to Screening until the end of study treatment. Subjects taking methotrexate are also advised to take folic acid 5 mg/week (or equivalent) if there is no contraindication.
4. Subjects receiving probiotics must be on a stable dose from the initial Screening visit until the end of study.
5. Subjects receiving an anti-diarrhetic must be on a stable dose for ≥ 2 weeks prior to Screening until the end of study.
7. Previous treatment with one or two advanced therapy that demonstrated an inadequate response and/or loss of response.
8. Negative pregnancy test during Screening and Day 1 (V0) in females of childbearing potential.
9. Females with reproductive potential must be sexually abstinent or be willing to use a highly effective method of contraception from study start to ≥ 3 months after the final dose of the study drug. Highly effective methods of contraception include:
1. Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); male partner should use a condom;
2. Intrauterine device or system; or
3. Surgical sterilization or partner sterile (must have documented proof).
10. Male subjects must be either surgically sterile (must have documented proof), agree to be sexually abstinent, or use a double-barrier method of birth control (e.g., condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration to ≥ 3 months after the final dose administration.
11. Male subjects must agree to refrain from donating sperm from first study drug administration to ≥ 3 months after final dose administration.

1. Diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID)-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC), or radiation-induced colitis.
2. Ulcerative colitis limited to the rectum (ulcerative proctitis).
3. Presence of short bowel syndrome.
4. History of colectomy, or presence of an ileostomy or colostomy.
5. History of, or active colonic mucosal dysplasia.
6. Treatment with any intravenous (IV) corticosteroid or rectal therapy during the Screening period.
7. Treatment with any calcineurin inhibitor (e.g., cyclosporine, tacrolimus) from the initial Screening visit.
8. Treatment with NSAIDs within 4 weeks prior to Screening. Short-term use (\<7 days) of NSAIDs for non-UC related symptoms is allowed.
9. Treatment with tofacitinib or other Janus Kinase (JAK) inhibitors from the initial Screening visit.
10. Treatment with sphingosine-1-phosphate receptor (S1PR) modulators from the initial Screening visit.
11. Biologic therapy within 56 days or 5 half-lives (whichever is longer) prior to Screening. Confirmation of undetectable or non-therapeutic serum levels, as assessed by the Investigator, will allow for eligibility.
12. Tube feeding, defined formula diets, or parenteral alimentation/nutrition within 3 weeks of first dosing.
13. Treatment with oral antibiotics within 4 weeks prior to Screening or IV antibiotics within 8 weeks prior to Screening.
14. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to Screening.
15. History of dysplasia or malignancy in the past 5 years, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
16. Subjects with a current or recent history of severe, progressive, or uncontrolled cardiac (including uncontrolled hypertension), renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological (e.g., history of seizures) disease, or any other severe comorbidity that, in the opinion of the Investigator, could confound the study results or put the subject at unreasonable risk.
17. Significant screening electrocardiogram (ECG) abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block.
18. For males, a QTc interval (Fridericia's correction) of \>450 ms, and for females, a QTc interval (Fridericia's correction) of \>470 ms.
19. Any of following laboratory abnormalities during the Screening period. If values are initially outside prescribed limits, the evaluation may be repeated once within the Screening period to determine eligibility:
1. Calculated creatinine clearance \< 60 mL/min
2. Serum transaminases \> 2.0x Upper Limit Normal (ULN)
3. Alkaline phosphatase (ALP) \> 2.0x ULN
4. Bilirubin \> 1.5x ULN; does not apply to subjects with Gilbert's Syndrome (Meulengracht Syndrome)
5. Hemoglobin \< 8g/dL
6. Platelets \< 75,000/μL
7. Absolute neutrophil count \< 1,500/ μL
8. Absolute lymphocyte count \< 800/ μL
20. Human immune deficiency virus (HIV) infection or known HIV-related malignancy.
21. Acute or chronic hepatitis B (HBV) or hepatitis C (HCV), or carrier status. Subjects with anti-HBc (hepatitis B core) antibodies (Ab) but with undetectable anti-HBs (hepatitis B surface) Ab should be excluded.
22. Positive immunoglobulin M (IgM) Ab titers in the presence of negative immunoglobulin G (IgG) Ab titers to Epstein-Barr virus (EBV).
23. Positive stool test for ova or parasites, positive stool culture for pathogens, or positive stool toxin assay for Clostridium difficile at Screening.
24. Active cytomegalovirus (CMV) infection at Screening, as assessed by the Investigator.
25. Positive QuantiFERON® TB test at Screening for latent Mycobacterium tuberculosis (TB) infection. If a QuantiFERON® TB test is indeterminate, the test should be repeated. If the result is again indeterminate, the subject should be excluded.
26. History of any opportunistic infection within 12 weeks of first dosing.
27. Any current or recent symptoms/signs of infection, except nasopharyngitis, within 4 weeks of first dosing.
28. Cirrhosis or active alcohol abuse, pr the judgment of the Investigator.
29. History of drug abuse according teo the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria within 12 months prior to Screening or a positive drug screening test.
30. Currently breast feeding, or pregnant.
31. Known hypersensitivity or intolerance to ALTB-268 or any of its excipients.
32. Participation in another clinical trial AND having received investigational medication within 30 days or 5 half-lives (whichever is longer) prior to Screening or having used an investigational device treatment within 30 days prior to Screening. Concurrent participation in an observational or long-term follow-up study and not actively receiving an investigational drug or device treatment may be eligible for participation in this study.
33. Inability to comply with the study protocol, in the opinion of the Investigator.

Contacts and Locations

Principal Investigator

David Lin, MD, PhD

STUDY_DIRECTOR

AltruBio Inc.

Study Locations (Sites)

San Diego Gastroenterology

San Diego, California, 92103

United States

Rocky Mountain Gastroenterology

Littleton, Colorado, 80120

United States

Gastro Health Research

Miami, Florida, 33176

United States

Digestive and Liver Center of Florida, LLC

Orlando, Florida, 32825

United States

Alliance Clinical Research of Tampa, LLC.

Tampa, Florida, 33615

United States

Gastro Health Partners Southern Indiana

New Albany, Indiana, 47150

United States

Gastro Health Partners Louisville

Louisville, Kentucky, 40218

United States

Louisiana Research Center, LLC.

Shreveport, Louisiana, 71105

United States

Gastroenterology Associates of North Mississippi

Oxford, Mississippi, 38655

United States

New York Presbyterian Hospital - Weill Cornell Medical Colllege

New York, New York, 10065

United States

Gastroenterology Group of Rochester

Rochester, New York, 14618

United States

Digestive Disease Medicine of Central New York

Utica, New York, 13502

United States

Dayton Gastroenterology, LLC

Beavercreek, Ohio, 45440

United States

Gastro Health Ohio

Liberty Township, Ohio, 45044

United States

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401

United States

Gastroenterology Associates, P.A.

Greenville, South Carolina, 29607

United States

DHAT / GI Aliance

Garland, Texas, 75044

United States

Caprock Gastro Reasearch

Lubbock, Texas, 19424

United States

GI Alliance

Mansfield, Texas, 760603

United States

Southern Star Research Institute LLC

San Antonio, Texas, 78229

United States

Tyler Research Institute

Tyler, Texas, 75701

United States

GI Alliance

Webster, Texas, 33016

United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215

United States

Collaborators and Investigators

Sponsor: AltruBio Inc.

David Lin, MD, PhD, STUDY_DIRECTOR, AltruBio Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04

Study Completion Date2027-03

Study Record Updates

Study Start Date2023-12-04

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

Ulcerative Colitis
Efficacy
Safety

Additional Relevant MeSH Terms

Ulcerative Colitis