What is the mechanism of action of this treatment?

Common treatments for Ulcerative Colitis (UC) include immunomodulators and anti-inflammatory agents. Immunomodulators, such as azathioprine and 6-mercaptopurine, work by altering the immune system's activity to reduce inflammation and prevent flare-ups. Anti-inflammatory agents, like mesalamine and corticosteroids, directly reduce inflammation in the colon. These treatments are crucial for UC patients as they help manage symptoms, maintain remission, and improve quality of life by controlling the chronic inflammation that characterizes the disease.

What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include 5-aminosalicylates (5-ASA), glucocorticoids, and immunomodulators. 5-ASA agents like mesalamine can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids, used for their anti-inflammatory properties, can lead to systemic side effects like adrenal suppression, especially with long-term use. Immunomodulators such as azathioprine and 6-mercaptopurine may cause bone marrow suppression, liver toxicity, and increased risk of infections. These treatments aim to reduce inflammation and maintain remission but require careful monitoring due to their potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, focusing on immunomodulators and anti-inflammatory agents. Key drugs include 5-aminosalicylates (5-ASA) like mesalamine and sulfasalazine, which target inflammation in the colon. Glucocorticoids such as prednisone are used for their potent anti-inflammatory effects. Biologic therapies, including anti-TNF agents like infliximab and adalimumab, target specific components of the immune system to reduce inflammation. These treatments aim to induce and maintain remission in patients with UC.

What other types of research exist?

Promising novel alternatives to APL-1401 for ulcerative colitis patients include AJM300, an oral antagonist of α4 integrin, which has shown efficacy in a phase 2a study for patients with moderately active UC. Additionally, other biologics like ustekinumab and vedolizumab, which have demonstrated efficacy in various clinical contexts, may also be considered, especially for patients who have failed anti-TNF therapy.

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APL-1401 for Ulcerative Colitis

Verified Trial

Phase 1

Recruiting

Research Sponsored by Jiangsu Yahong Meditech Co., Ltd aka Asieris

Eligibility Criteria Checklist

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

Must have

Are you between 18-65 years of age?

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 28

Summary

This trial tests a new drug, APL-1401, taken daily by mouth, on patients with severe Ulcerative Colitis. It aims to find the safest and most effective dose over a few weeks.

Who is the study for?

Adults aged 18-65 with moderately to severely active Ulcerative Colitis (UC) can join this trial. They must have a UC diagnosis for at least 3 months, a Total Mayo Score of 6-12, and be on stable doses of certain medications. Women must test negative for pregnancy and use two birth control methods; men also need to follow specific contraception guidelines.

What is being tested?

APL-1401 is being tested against a placebo in this study. Participants will randomly receive either the drug or placebo without knowing which one they're getting. The trial includes initial screening, treatment over four weeks, and follows up safety checks until day 58.

What are the potential side effects?

While the side effects of APL-1401 are not detailed here, typical side effects in such trials may include digestive issues like nausea or diarrhea, potential allergic reactions, fatigue, headaches, and possibly increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 28 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants adverse events (AEs)

Number of Participants adverse events of special interest (AESI)

Number of Participants serious adverse events (SAEs)

Secondary study objectives

AUC

AUC0-24

AUClast

+11 more

Other study objectives

CRP

ESR

Fecal calprotectin

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: APL-1401Experimental Treatment1 Intervention

On Day 1, patients will be randomized to receive either APL-1401 or placebo in a 5:1 ratio. Patients will receive APL-1401 orally once daily (QD) during the 28-day treatment period.

Group II: PlaceboPlacebo Group1 Intervention

Identically matching placebo capsules once daily for 28 days

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ulcerative Colitis (UC) include immunomodulators and anti-inflammatory agents. Immunomodulators, such as azathioprine and 6-mercaptopurine, work by altering the immune system's activity to reduce inflammation and prevent flare-ups. Anti-inflammatory agents, like mesalamine and corticosteroids, directly reduce inflammation in the colon. These treatments are crucial for UC patients as they help manage symptoms, maintain remission, and improve quality of life by controlling the chronic inflammation that characterizes the disease.

Emerging Therapies for Inflammatory Bowel Diseases.