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

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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, a Maintenance Phase, and an OLE.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

‣ 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.

Locations
United States
California
San Diego Gastroenterology
RECRUITING
San Diego
Colorado
Rocky Mountain Gastroenterology
RECRUITING
Littleton
Florida
Gastro Health Research
RECRUITING
Miami
Digestive and Liver Center of Florida, LLC
RECRUITING
Orlando
Alliance Clinical Research of Tampa, LLC.
RECRUITING
Tampa
Indiana
Gastro Health Partners Southern Indiana
RECRUITING
New Albany
Kentucky
Gastro Health Partners Louisville
RECRUITING
Louisville
Louisiana
Louisiana Research Center, LLC.
RECRUITING
Shreveport
Mississippi
Gastroenterology Associates of North Mississippi
RECRUITING
Oxford
New York
New York Presbyterian Hospital - Weill Cornell Medical Colllege
RECRUITING
New York
Gastroenterology Group of Rochester
RECRUITING
Rochester
Digestive Disease Medicine of Central New York
RECRUITING
Utica
Ohio
Dayton Gastroenterology, LLC
RECRUITING
Beavercreek
Gastro Health Ohio
RECRUITING
Liberty Township
Pennsylvania
Frontier Clinical Research, LLC
RECRUITING
Uniontown
South Carolina
Gastroenterology Associates, P.A.
RECRUITING
Greenville
Texas
DHAT / GI Aliance
RECRUITING
Garland
Caprock Gastro Reasearch
RECRUITING
Lubbock
GI Alliance
RECRUITING
Mansfield
Southern Star Research Institute LLC
RECRUITING
San Antonio
Tyler Research Institute
RECRUITING
Tyler
GI Alliance
RECRUITING
Webster
Wisconsin
Wisconsin Center for Advanced Research
RECRUITING
Milwaukee
Other Locations
Puerto Rico
Wellness Clinical Research, LLC
RECRUITING
Vega Baja
Contact Information
Primary
Simona Reed, PhD
simona.reed@altrubio.com
17142150224
Time Frame
Start Date: 2023-12-04
Estimated Completion Date: 2026-11
Participants
Target number of participants: 50
Treatments
Other: ALTB-268
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 20 biweekly doses of ALTB-268 will be administered in the 40 week maintenance study period.
Sponsors
Leads: AltruBio Inc.

This content was sourced from clinicaltrials.gov

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