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?

This trial tests a new treatment, ALTB-268, for individuals with moderately to severely active ulcerative colitis (UC), a condition that causes inflammation and sores in the colon. The study aims to evaluate the effectiveness and safety of this treatment over several weeks. Participants will receive ALTB-268 through a series of injections. Those diagnosed with UC for at least 12 weeks and experiencing significant symptoms may be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in UC treatment.

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.

Is there any evidence suggesting that ALTB-268 is likely to be safe for humans?

Research has shown that ALTB-268 has promising safety results from earlier studies. In both lab and early human trials, the treatment was generally well-tolerated, with most participants not experiencing serious side effects. This suggests it might be safe for use. However, the treatment remains under investigation, and further information is needed to confirm its safety. Prospective participants should discuss any concerns with their doctor before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ulcerative colitis, which often include oral medications or intravenous infusions, ALTB-268 is administered through subcutaneous injection. This method can offer more convenience and potentially fewer side effects. Additionally, ALTB-268 introduces a new active ingredient that targets ulcerative colitis differently, possibly offering enhanced efficacy. Researchers are excited about ALTB-268 because it has the potential to improve the quality of life for patients with a more streamlined and effective treatment option.

What evidence suggests that ALTB-268 might be an effective treatment for ulcerative colitis?

Research has shown that ALTB-268, the investigational treatment in this trial, might help treat ulcerative colitis by reducing inflammation. In a study with mice, ALTB-268 significantly reduced inflammation, indicating it can calm the immune system. Although detailed information from human studies remains limited, these early results suggest that ALTB-268 could be effective for ulcerative colitis. This trial's ongoing research aims to confirm these promising results in people with the condition. ^{4 6 7 8 9}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06109441

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to ... 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 ...

2. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/abgn-268-altrubio-ulcerative-colitis-likelihood-of-approval/

AbGn-268 by AltruBio for Ulcerative Colitis: Likelihood of ... AbGn-268 is under clinical development by AltruBio and currently in Phase II for Ulcerative Colitis. According to GlobalData, Phase II drugs for Ulcerative ...

3. pryzm.ozmosi.com pryzm.ozmosi.com/product/26089

Leiolizumab Drug Profile Real-world comparison of the effectiveness between ustekinumab and vedolizumab in patients with ulcerative colitis exposed to at least one anti-TNF agent.

4. synapse.patsnap.com synapse.patsnap.com/drug/f7125b55a6984cee951a4a6fe06627c7

Leiolizumab - Drug Targets, Indications, Patents Currently being evaluated in a Phase 2 trial in ulcerative colitis, ALTB-268 holds the potential to be a pipeline in a product to address a range of ...

5. altrubio.com altrubio.com/altrubio/en/news/akjrkgjllyex

News & Events ALTB-268 demonstrated its anti-inflammatory effect in an acute colitis hPSGL-1 mouse model. The data confirmed that ALTB-268 acts as an immune ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06109441

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to ... 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 ...

7. altrubio.com altrubio.com/altrubio/en/product/detail/ALTB268

ALTB-268 From preclinical and phase 1 clinical studies ALTB-268 exhibits not only comparable safety ... Ulcerative Colitis. 1. PRECLINICAL. PHASE I. PHASE IIA. Phase II.

8. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/abgn-268-altrubio-psoriatic-arthritis-likelihood-of-approval/

AbGn-268 by AltruBio for Psoriatic Arthritis: Likelihood of ... AbGn-168H2 (c) is under development for the treatment of ulcerative colitis and psoriatic arthritis. The drug candidate is a humanized ...

9. adisinsight.springer.com adisinsight.springer.com/drugs/800052080

Leiolizumab - AltruBio - AdisInsight - Springer Leiolizumab (also known as AbGn 168H2) is a second generation, tetravalent P‐selectin glycoprotein ligand‐1 (PSGL‐1) antibody agonist, being developed by.