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ALTB-268 for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+33 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AltruBio Inc.

Must be taking: Corticosteroids, 5-ASA, Immunosuppressants

Must not be taking: NSAIDs, JAK inhibitors, Biologics

Disqualifiers: Crohn's, Colectomy, Dysplasia, HIV, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 Maintenance Phase. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268 followed by weekly doses of ALTB-268 for 12 weeks. Primary efficacy endpoint will be evaluated at week 12. Week 12 dosing will occur during the 40 wks Maintenance Phase. During 40 weeklong maintenance phase SC doses of ALTB-268 will be administered every other week. At week 52, all subjects will have an endoscopy performed and efficacy and safety evaluation will take place.

Will I have to stop taking my current medications?

The trial requires that you stay on stable doses of certain medications, like oral corticosteroids, 5-aminosalicylic acid, immunosuppressants, probiotics, and anti-diarrhetics, from before the trial starts until the end. However, you must stop taking certain other medications, like NSAIDs, calcineurin inhibitors, and biologic therapies, before the trial begins.

Research Team

Jesse Hall, MD

Principal Investigator

AltruBio Inc.

Eligibility Criteria

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.

Inclusion Criteria

Willing to provide informed consent and to be compliant with the schedule of study visits and protocol assessments

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

I tried a biologic therapy before, but it didn't work well or stopped working.

See 9 more

Exclusion Criteria

I have short bowel syndrome.

I have not had any infections, except for a cold, in the last 4 weeks.

I have not been on tube feeding or IV nutrition in the last 3 weeks.

See 29 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Induction

Participants receive a SC loading dose of ALTB-268 followed by weekly doses for 12 weeks

12 weeks

Weekly visits (in-person)

Maintenance

Participants receive SC doses of ALTB-268 every other week for 40 weeks

40 weeks

Biweekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

ALTB-268 (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.