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

NCT06109441 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: ALTB-268-201
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 24

Brief 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)

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• 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.

  week 12

Secondary Outcomes (13)

• Efficacy - clinical response

  week 12

• Efficacy - clinical remission

  week 12

• Efficacy - endoscopic improvement

  week 12

• Efficacy - endoscopic remission

  week 12

• Efficacy - histological remission (RHI)

  week 12

Study Arms (1)

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.

Biological: ALTB-268

Interventions

ALTB-268 BIOLOGICAL

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.

ALTB-268

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AltruBio Inc.: lead

Study Sites (24)

San Diego Gastroenterology

San Diego, California, 92103, United States

Location

Rocky Mountain Gastroenterology

Littleton, Colorado, 80120, United States

Location

Gastro Health Research

Miami, Florida, 33176, United States

Location

Digestive and Liver Center of Florida, LLC

Orlando, Florida, 32825, United States

Location

Alliance Clinical Research of Tampa, LLC.

Tampa, Florida, 33615, United States

Location

Gastro Health Partners Southern Indiana

New Albany, Indiana, 47150, United States

Location

Gastro Health Partners Louisville

Louisville, Kentucky, 40218, United States

Location

Louisiana Research Center, LLC.

Shreveport, Louisiana, 71105, United States

Location

Gastroenterology Associates of North Mississippi

Oxford, Mississippi, 38655, United States

Location

New York Presbyterian Hospital - Weill Cornell Medical Colllege

New York, New York, 10065, United States

Location

Gastroenterology Group of Rochester

Rochester, New York, 14618, United States

Location

Digestive Disease Medicine of Central New York

Utica, New York, 13502, United States

Location

Dayton Gastroenterology, LLC

Beavercreek, Ohio, 45440, United States

Location

Gastro Health Ohio

Liberty Township, Ohio, 45044, United States

Location

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401, United States

Location

Gastroenterology Associates, P.A.

Greenville, South Carolina, 29607, United States

Location

DHAT / GI Aliance

Garland, Texas, 75044, United States

Location

Caprock Gastro Reasearch

Lubbock, Texas, 19424, United States

Location

GI Alliance

Mansfield, Texas, 760603, United States

Location

Southern Star Research Institute LLC

San Antonio, Texas, 78229, United States

Location

Tyler Research Institute

Tyler, Texas, 75701, United States

Location

GI Alliance

Webster, Texas, 33016, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

Wellness Clinical Research, LLC

Vega Baja, 00693, Puerto Rico

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• David Lin, MD, PhD

  AltruBio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 31, 2023
• Study Start: December 4, 2023
• Primary Completion: March 5, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (23); PR (1)