ALTB-268 for Ulcerative Colitis

Recruiting at 33 trial locations

Overseen By Simona Reed, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

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, a Maintenance Phase, and an OLE.

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.

Who Is on the Research Team?

David Lin, MD, PhD

Principal Investigator

AltruBio Inc.

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• ALTB-268

Trial Overview 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.

How Is the Trial Designed?

Group I: ALTB-268 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

AltruBio Inc.

Lead Sponsor

Trials

4

Recruited

150+