Ulcerative ColitisPhase 2NCT06109441
Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics
A Phase 2 study testing ALTB-268 in people with Ulcerative Colitis, run by AltruBio Inc. at 24 sites in 2 countries.
Trial summary
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 and a LTE (Long Term Extension) 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-268
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 4 Dec 2023to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Adult participants 18 to 75 years old, inclusive, at Screening.
- Willing to provide informed consent and to be compliant with the schedule of study visits and protocol assessments.
- Diagnosis of UC established at least 12 weeks prior to Screening by standard clinical and endoscopic evidence and corroborated by a histopathology report.
- 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.
- Evidence of active UC, extending proximal to the rectum with ≥ 15 cm of involved colon.
- Stable doses of concomitant medications:
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- 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.
- Subjects receiving oral 5-aminosalicylic acid (5-ASA) must be on a stable dose from the initial Screening visit until the end of study.
- 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.
- Subjects receiving probiotics must be on a stable dose from the initial Screening visit until the end of study.
- Subjects receiving an anti-diarrhetic must be on a stable dose for ≥ 2 weeks prior to Screening until the end of study.
- Previous treatment with one or two advanced therapy that demonstrated an inadequate response and/or loss of response.
- Negative pregnancy test during Screening and Day 1 (V0) in females of childbearing potential.
- 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:
- Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); male partner should use a condom;
- Intrauterine device or system; or
- Surgical sterilization or partner sterile (must have documented proof).
- 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.
- Male subjects must agree to refrain from donating sperm from first study drug administration to ≥ 3 months after final dose administration.
Who cannot join
- 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.
- Ulcerative colitis limited to the rectum (ulcerative proctitis).
- Presence of short bowel syndrome.
- History of colectomy, or presence of an ileostomy or colostomy.
- History of, or active colonic mucosal dysplasia.
- Treatment with any intravenous (IV) corticosteroid or rectal therapy during the Screening period.
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- Treatment with any calcineurin inhibitor (e.g., cyclosporine, tacrolimus) from the initial Screening visit.
- Treatment with NSAIDs within 4 weeks prior to Screening. Short-term use (<7 days) of NSAIDs for non-UC related symptoms is allowed.
- Treatment with tofacitinib or other Janus Kinase (JAK) inhibitors from the initial Screening visit.
- Treatment with sphingosine-1-phosphate receptor (S1PR) modulators from the initial Screening visit.
- 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.
- Tube feeding, defined formula diets, or parenteral alimentation/nutrition within 3 weeks of first dosing.
- Treatment with oral antibiotics within 4 weeks prior to Screening or IV antibiotics within 8 weeks prior to Screening.
- Vaccination with a live or live-attenuated vaccine within 4 weeks prior to Screening.
- 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.
- 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.
- Significant screening electrocardiogram (ECG) abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block.
- For males, a QTc interval (Fridericia's correction) of >450 ms, and for females, a QTc interval (Fridericia's correction) of >470 ms.
- 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:
- Calculated creatinine clearance < 60 mL/min
- Serum transaminases > 2.0x Upper Limit Normal (ULN)
- Alkaline phosphatase (ALP) > 2.0x ULN
- Bilirubin > 1.5x ULN; does not apply to subjects with Gilbert's Syndrome (Meulengracht Syndrome)
- Hemoglobin < 8g/dL
- Platelets < 75,000/μL
- Absolute neutrophil count < 1,500/ μL
- Absolute lymphocyte count < 800/ μL
- Human immune deficiency virus (HIV) infection or known HIV-related malignancy.
- 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.
- Positive immunoglobulin M (IgM) Ab titers in the presence of negative immunoglobulin G (IgG) Ab titers to Epstein-Barr virus (EBV).
- Positive stool test for ova or parasites, positive stool culture for pathogens, or positive stool toxin assay for Clostridium difficile at Screening.
- Active cytomegalovirus (CMV) infection at Screening, as assessed by the Investigator.
- 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.
- Subjects with a history of latent TB infection who received or are receiving an appropriate and documented course of therapy can be included if the screening examination and a chest x-ray performed within 3 months prior to Screening revealed no evidence of current active infection.
- History of any opportunistic infection within 12 weeks of first dosing.
- Any current or recent symptoms/signs of infection, except nasopharyngitis, within 4 weeks of first dosing.
- Cirrhosis or active alcohol abuse, pr the judgment of the Investigator.
- 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.
- Currently breast feeding, or pregnant.
- Known hypersensitivity or intolerance to ALTB-268 or any of its excipients.
- 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.
- Inability to comply with the study protocol, in the opinion of the Investigator.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States23 sites
Dayton Gastroenterology, LLC
Beavercreek, Ohio, 45440
DHAT / GI Aliance
Garland, Texas, 75044
Gastroenterology Associates, P.A.
Greenville, South Carolina, 29607
Gastro Health Ohio
Liberty Township, Ohio, 45044
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120
Gastro Health Partners Louisville
Louisville, Kentucky, 40218
Caprock Gastro Reasearch
Lubbock, Texas, 19424
GI Alliance
Mansfield, Texas, 760603
Gastro Health Research
Miami, Florida, 33176
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Gastro Health Partners Southern Indiana
New Albany, Indiana, 47150
New York Presbyterian Hospital - Weill Cornell Medical Colllege
New York, New York, 10065
Digestive and Liver Center of Florida, LLC
Orlando, Florida, 32825
Gastroenterology Associates of North Mississippi
Oxford, Mississippi, 38655
Gastroenterology Group of Rochester
Rochester, New York, 14618
Southern Star Research Institute LLC
San Antonio, Texas, 78229
San Diego Gastroenterology
San Diego, California, 92103
Louisiana Research Center, LLC.
Shreveport, Louisiana, 71105
Alliance Clinical Research of Tampa, LLC.
Tampa, Florida, 33615
Tyler Research Institute
Tyler, Texas, 75701
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401
Digestive Disease Medicine of Central New York
Utica, New York, 13502
GI Alliance
Webster, Texas, 33016
About this study
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
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 and a LTE (Long Term Extension)
Read the detailed 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 and a LTE. Upon successful completion of the Screening Phase, subjects will return to the clinic for their first visit, which must occur within 28 days of the initial Screening Visit. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268, followed by a weekly maintenance dose of ALTB-268 in the 12-week Induction Study Phase. Participants entering the LTE will continue to receive the SC dose of ALTB-268 weekly or biweeky, up to 2 years. Upon completion of the LTE, study participants will be asked to return for an end of study visit in approximately 4 weeks.
- Conditions
- Ulcerative Colitis
- Being tested
- ALTB-268
- Keywords
- Ulcerative Colitis, Efficacy, Safety
- 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-268Biological
ALTB-268 drug product (DP) for SC injection is supplied as a sterile and preservative-free frozen solution or lyophilized powder. All excipients used in the DP formulation are of multi-compendial quality and have precedence for use in parenteral products.
| Study group | Role | What they receive |
|---|---|---|
| ALTB-268 | Other | ALTB-268 IP will be administered via subcutaneous injection. One loading dose will be followed by 10 weekly doses of ALTB-268 in the 12 weeks induction study phase. Additional weekly or biweekly doses of ALTB-268 will be administered in the 2-year LTE period. Receives: Biological: ALTB-268 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - change in mMS
Change from baseline in mMS at Week 12. The modified Mayo score (mMayo Score) is a measure of disease activity in ulcerative colitis. It is based on stool frequency (SF), rectal bleeding (RB), and endoscopic subscore (ES). The mMS ranges from 0 to 9. A lower mMS means less severe UC, and a higher mMS means more severe UC.
Measured: week 12
Secondary outcomes (13)
Efficacy - clinical response
The proportion of subjects with clinical response at Week 12, defined as a decrease from baseline in the mMS of ≥ 2 points AND at least a 30% reduction from the baseline score, AND a decrease in the RB subscore of ≥ 1 point or an absolute RB score of 0 or 1.
Measured: week 12
Efficacy - clinical remission
The proportion of subjects with clinical remission at Week 12, defined as mMS of ≤ 2 points, with a SF subscore of ≤ 1 point, a RB subscore of 0, and an endoscopic subscore of ≤ 1 point.
Measured: week 12
Efficacy - endoscopic improvement
The proportion of subjects with endoscopic improvement, defined as a centrally read endoscopy score of ≤1 at Week 12.
Measured: week 12
Efficacy - endoscopic remission
The proportion of subjects with endoscopic remission, defined as a centrally read endoscopy score of 0 at Week 12.
Measured: week 12
Efficacy - histological remission (RHI)
Histological remission, defined as a Robarts Histopathology Index (RHI) Score of ≤ 3 at Week 12.
Measured: week 12
Efficacy - change from baseline in Geboes score
Change from baseline in Geboes score at week 12.
Measured: week 12
Efficacy -Change from baseline in pMS
change from baseline in pMS at Week 12
Measured: week 12
Efficacy - change in individual mMS subscores
Change in individual mMS subscores at week 12
Measured: week 12
Efficacy - change from baseline in pMS
Measured: week 12 and week 52
Efficacy - change in mMS
Change in individual mMS subscores
Measured: week 12 and week 52
Efficacy - change in IBDQ score
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score at Week 12
Measured: week 12
Efficacy - change from baseline in fecal calprotectin
change from baseline in fecal calprotectin at Week 12
Measured: week 12
Efficacy - change from baseline in C-reactive protein (CRP)
change from baseline in CRP at Week 12
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start4 Dec 2023
- Primary completion5 Mar 2026
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AltruBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Lin, MD, PhD, Study director, AltruBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109441
- Sponsor's protocol ID
- ALTB-268-201
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2023
- Last updated
- 5 May 2026
- Results posted
- No
- 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06109441
- Acronym / sponsor ID
- ALTB-268-201
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AltruBio Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and a LTE (Long Term Extension)
Detailed 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 and a LTE. Upon successful completion of the Screening Phase, subjects will return to the clinic for their first visit, which must occur within 28 days of the initial Screening Visit. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268, followed by a weekly maintenance dose of ALTB-268 in the 12-week Induction Study Phase. Participants entering the LTE will continue to receive the SC dose of ALTB-268 weekly or biweeky, up to 2 years. Upon completion of the LTE, study participants will be asked to return for an end of study visit in approximately 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALTB-268 | Other | Biological: ALTB-268ALTB-268 IP will be administered via subcutaneous injection. One loading dose will be followed by 10 weekly doses of ALTB-268 in the 12 weeks induction study phase. Additional weekly or biweekly doses of ALTB-268 will be administered in the 2-year LTE period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adult participants 18 to 75 years old, inclusive, at Screening.
- Willing to provide informed consent and to be compliant with the schedule of study visits and protocol assessments.
- Diagnosis of UC established at least 12 weeks prior to Screening by standard clinical and endoscopic evidence and corroborated by a histopathology report.
- 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.
- Evidence of active UC, extending proximal to the rectum with ≥ 15 cm of involved colon.
Key exclusion criteria (42 listed)
- 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.
- Ulcerative colitis limited to the rectum (ulcerative proctitis).
- Presence of short bowel syndrome.
- History of colectomy, or presence of an ileostomy or colostomy.
- History of, or active colonic mucosal dysplasia.
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-268ALTB-268 drug product (DP) for SC injection is supplied as a sterile and preservative-free frozen solution or lyophilized powder. All excipients used in the DP formulation are of multi-compendial quality and have precedence for use in parenteral products. | Biological | ALTB-268 |
Primary outcome
Efficacy - change in mMS
Time frame: week 12
Change from baseline in mMS at Week 12. The modified Mayo score (mMayo Score) is a measure of disease activity in ulcerative colitis. It is based on stool frequency (SF), rectal bleeding (RB), and endoscopic subscore (ES). The mMS ranges from 0 to 9. A lower mMS means less severe UC, and a higher mMS means more severe UC.
13 secondary outcomes
Efficacy - clinical response
Time frame: week 12
Efficacy - clinical remission
Time frame: week 12
Efficacy - endoscopic improvement
Time frame: week 12
Efficacy - endoscopic remission
Time frame: week 12
Efficacy - histological remission (RHI)
Time frame: week 12
Efficacy - change from baseline in Geboes score
Time frame: week 12
Efficacy -Change from baseline in pMS
Time frame: week 12
Efficacy - change in individual mMS subscores
Time frame: week 12
Efficacy - change from baseline in pMS
Time frame: week 12 and week 52
Efficacy - change in mMS
Time frame: week 12 and week 52
Efficacy - change in IBDQ score
Time frame: week 12
Efficacy - change from baseline in fecal calprotectin
Time frame: week 12
Efficacy - change from baseline in C-reactive protein (CRP)
Time frame: week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- 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.
David Lin, MD, PhD study director
AltruBio Inc.
24 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-268 in people with Ulcerative Colitis, run by AltruBio Inc. at 24 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 19 inclusion and 42 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
This study is still under way. Results are not available in the source record yet.
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?
Efficacy - change in mMS (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 May 2026.