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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 and week 52
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy - change in mMS at week 12
Secondary outcome measures
Efficacy - Histological remission, defined as a Geboes score of ≤ 2
Efficacy - change in IBDQ score
Efficacy - change in mMS
+9 more
Other outcome measures
Immunogenicity

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

Find a Location

Who is running the clinical trial?

AltruBio Inc.Lead Sponsor
3 Previous Clinical Trials
117 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
24 Patients Enrolled for Ulcerative Colitis
Jesse Hall, MDStudy DirectorAltruBio Inc.
4 Previous Clinical Trials
126 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor accept individuals over the age of 70?

"The age requirements for this trial are 18-75 years of age."

Answered by AI

Are there ample venues for this clinical trial in Canada?

"At this time, the study is running in 7 distinct medical centres located around Garland, Lubbock and Mansfield. To alleviate any extra strain or stress due to travel demands, it's crucial to select the closest trial site for participation."

Answered by AI

How many people have been enlisted to partake in this medical investigation?

"Affirmative. Per the information on clinicaltrials.gov, this research project is still recruiting participants. Initially published on November 1st 2023 and last edited on June 11th 2023, it requires 15 subjects across 7 different medical centres to complete the trial."

Answered by AI

What kind of safety parameters have been established for ALTB-268?

"Our team at Power evaluated ALTB-268's safety and awarded it a score of 2. This is because the medication has been through Phase 2 trials, providing some evidence that it does not pose an unacceptable risk to patients but no data yet supporting its efficacy."

Answered by AI

Are participants being recruited for this experiment at this time?

"Indicated by the clinicaltrials.gov website, this trial is still recruiting patients. It was originally published on November 1st 2023 and has since been updated as recently as November 6th 2023."

Answered by AI

Is it possible to join this experiment?

"This clinical trial is currently recruiting 15 participants with active ulcerative colitis aged 18-75. To be eligible, patients must meet the following criteria: adults between ages 18 and 75 at screening, willing to provide informed consent and follow protocol assessments, diagnosis of UC established ≥ 12 weeks before Screening backed by endoscopic/histopathology evidence; mMS score 4–9 inclusive & RB subscore ≥ 1; active UC extending proximal to rectum w/≥15 cm involved colon; prior unsuccessful biologic therapy response or loss of response; negative pregnancy test in females of childbearing potential during Screening/Day 1 ("

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics
2023. "Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06109441.
~20 spots leftby Apr 2025
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