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Monoclonal Antibodies

ALTB-268 for Ulcerative Colitis

Phase 2

Recruiting

Research Sponsored by AltruBio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult participants 18 to 75 years old, inclusive, at Screening

Evidence of active UC, extending proximal to the rectum with ≥ 15 cm of involved colon

Must not have

Presence of short bowel syndrome

History of colectomy, or presence of an ileostomy or colostomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 and week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess a new drug, ALTB-268, for safety and effectiveness in treating moderate to severe ulcerative colitis. Subjects will receive weekly doses for 12 weeks, followed by bi-weekly doses for 40 weeks.

Who is the study for?

Adults aged 18-75 with moderate to severe ulcerative colitis (UC) that hasn't improved after biologic therapy can join. They must have a UC diagnosis for at least 12 weeks, an active disease extending beyond the rectum, and agree to contraception or abstinence. Excluded are those with colectomy, recent severe illness, certain medication use within specified periods before screening, live vaccine recipients within four weeks prior to screening, and individuals with infections like HIV or hepatitis.

What is being tested?

The trial is testing ALTB-268's effectiveness and safety in treating UC over a period of up to 52 weeks. Participants will receive an initial loading dose followed by weekly doses for 12 weeks (Induction Phase), then every other week during the Maintenance Phase. The main goal is measured at week 12; endoscopy and evaluations occur at week 52.

What are the potential side effects?

While specific side effects of ALTB-268 aren't listed here, common side effects from similar treatments include injection site reactions, gastrointestinal symptoms like nausea or diarrhea, potential increased risk of infection due to immune system alteration, headaches, fatigue and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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My ulcerative colitis affects more than 15 cm of my colon beyond the rectum.

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My ulcerative colitis is moderate to severe, with significant bleeding.

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I am a male and will not father a child during or for 3 months after the study.

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My ulcerative colitis was diagnosed over 12 weeks ago, confirmed by tests and a biopsy report.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have short bowel syndrome.

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I have had surgery to remove my colon or have an ileostomy or colostomy.

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I have not received IV or rectal corticosteroid treatments recently.

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My heart's electrical cycle length is within safe limits.

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I am HIV positive or have an HIV-related cancer.

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My ulcerative colitis affects only my rectum.

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I have been diagnosed with a specific type of colitis not related to ulcerative colitis.

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I have not received a live vaccine in the last 4 weeks.

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I have a history of abnormal growths in my colon.

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I haven't taken tofacitinib or any JAK inhibitors in the last 4 weeks.

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I do not have active hepatitis B or C, nor am I a carrier.

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I have recent exposure to Epstein-Barr virus, shown by my blood test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy - change in mMS at week 12

Secondary study objectives

Efficacy - Histological remission, defined as a Geboes score of ≤ 2

Efficacy - change in IBDQ score

Efficacy - change in mMS

+9 more

Other study objectives

Immunogenicity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ALTB-268Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ALTB-268

2023

Completed Phase 1

~60

0 / 17Eligibility criteria met