APL-1401 for Ulcerative Colitis

Recruiting at 5 trial locations

Overseen By Qiuyue QU

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu Yahong Meditech Co., Ltd aka Asieris

Must be taking: Oral 5-ASA, Corticosteroids

Must not be taking: Intravenous corticosteroids, JAK inhibitors

Disqualifiers: Crohn's, HIV, Hepatitis, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called APL-1401 for people with ulcerative colitis, a condition that inflames the colon and causes symptoms like abdominal pain and frequent diarrhea. The study aims to determine if APL-1401 is safe and effective for those with moderately to severely active symptoms. Participants will receive either APL-1401 or a placebo (a pill with no active drug) to compare results. Those with active ulcerative colitis for at least three months and experiencing frequent symptoms like rectal bleeding or increased stool frequency might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain medications like oral 5-ASA and oral corticosteroids if the doses are stable. However, you must stop taking other medications like intravenous corticosteroids, topical 5-ASA, and certain immunosuppressants before joining the trial. Please check with the trial team for specific guidance on your medications.

Is there any evidence suggesting that APL-1401 is likely to be safe for humans?

Research shows that APL-1401 remains in the early testing stages, meaning complete safety information for humans is not yet available. This phase primarily assesses how well people tolerate the treatment. So far, these early studies have not widely reported serious side effects. As APL-1401 undergoes safety testing, researchers closely monitor any side effects or reactions. Progression to later trial stages typically indicates promising early safety results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Researchers are excited about APL-1401 for ulcerative colitis because it offers a novel approach compared to current treatments like corticosteroids, aminosalicylates, and biologics. Unlike these standard options, APL-1401 is taken orally once daily and may provide a more convenient treatment option. Additionally, its unique mechanism might target the underlying inflammation in a different way, potentially leading to quicker relief and fewer side effects. This innovative approach could be a game-changer for patients seeking more effective and manageable solutions for ulcerative colitis.

What evidence suggests that APL-1401 might be an effective treatment for ulcerative colitis?

Initial findings suggest that APL-1401, which participants in this trial may receive, shows promise in treating ulcerative colitis (UC). Research indicates it may help reduce colon inflammation, a major issue in UC. Early results have shown positive effects in patients with moderate to severe UC. Experts believe APL-1401 works by blocking certain processes in the body that lead to inflammation. While researchers continue to collect detailed information, these early signs are encouraging for those seeking new treatment options. ^{1 2 5 6 7}

Who Is on the Research Team?

Qiuyue QU

Principal Investigator

Jiangsu Yahong Meditech Co., Ltd aka Asieris

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I haven't used topical 5-ASA or steroids like enemas or suppositories in the last 2 weeks.

I have not taken JAK inhibitors like tofacitinib or upadacitinib in the last 4 weeks.

I have not taken intravenous corticosteroids in the week before joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive APL-1401 or placebo orally once daily for 28 days

4 weeks

4 visits (in-person)

Safety Follow-up

Participants are monitored for safety and adverse events after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• APL-1401
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: APL-1401 Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Identically matching placebo capsules once daily for 28 days

APL-1401 is already approved in United States, China for the following indications:

Approved in United States as APL-1401 for:

• None approved; currently in Phase 1b clinical trial for moderately to severely active ulcerative colitis

Approved in China as APL-1401 for:

• None approved; currently in Phase 1b clinical trial for moderately to severely active ulcerative colitis

Who Is Running the Clinical Trial?

Jiangsu Yahong Meditech Co., Ltd aka Asieris

Lead Sponsor

Trials

8

Recruited

1,700+

Published Research Related to This Trial

Recent phase 2/3 studies have shown promising efficacy and safety for novel therapeutic agents, including JAK inhibitors and IL23 blockers, in treating active ulcerative colitis, addressing the significant unmet need for effective treatments.

These new drugs may offer clinical, endoscopic, and histologic remission options for patients who do not respond to existing therapies, potentially transforming the treatment landscape for ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging drugs for the treatment of moderately to severely active ulcerative colitis: review of phase II and III clinical trials. Neurath, L., D'Amico, F., Danese, S.[2023]

Vedolizumab is significantly more effective than placebo for inducing clinical remission and endoscopic remission in patients with moderate to severe ulcerative colitis, based on a systematic review of four studies involving 606 patients.

The safety profile of vedolizumab is comparable to placebo, with no significant difference in adverse events, and fewer patients withdrew from treatment due to adverse events compared to those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab for induction and maintenance of remission in ulcerative colitis. Bickston, SJ., Behm, BW., Tsoulis, DJ., et al.[2018]

Tumor necrosis factor α inhibitors have significantly improved the treatment of moderate-to-severe ulcerative colitis, and the introduction of vedolizumab offers a new biologic option that specifically targets gut-specific leukocyte trafficking.

Despite the effectiveness of biologics in clinical practice, there remains uncertainty about which patient subsets benefit the most and how to optimize their use, highlighting a gap between clinical trial results and real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The biologics of ulcerative colitis. Macaluso, FS., Renna, S., Orlando, A., et al.[2018]

Golimumab, a new anti-TNF agent approved for ulcerative colitis, has shown effectiveness in inducing and maintaining clinical remission and mucosal healing, with safety confirmed in registration trials.

While golimumab's efficacy is similar to that of infliximab and adalimumab, it offers advantages in administration (subcutaneous vs intravenous) and dosing frequency (every 4 weeks vs every 2 weeks), making it a more convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Golimumab for moderately to severely active ulcerative colitis. Kedia, S., Ahuja, V., Makharia, GK.[2017]

In a study of 33 ulcerative colitis patients who switched from infliximab (IFX) to adalimumab (ADL), only 45% showed a clinical response after 12 weeks, and 18% achieved clinical remission, indicating modest short-term efficacy.

Long-term follow-up after one year revealed that 34% of patients had a clinical response and 26% were in clinical remission, but the colectomy rate was higher than expected, with 15% of patients undergoing surgery mainly due to primary ADL failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome of adalimumab therapy in patients with ulcerative colitis previously treated with infliximab: a Danish single-center cohort study. Christensen, KR., Steenholdt, C., Brynskov, J.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05743010

NCT05743010 | A Phase 1b Study to Evaluate APL-1401 ... This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 ...

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/fda-ind-asieris-uc/

US FDA grants IND clearance for Asieris' ulcerative colitis ... The trial will assess the safety, tolerability, pharmacokinetics, and initial efficacy of APL-1401 in UC patients. Vishnu Priya N November ...

3. linkedin.com linkedin.com/posts/asieris-pharmaceuticals_clinicaltrials-pharma-ulcerativecolitis-activity-7357375923354025984-BFxH

Asieris Pharmaceuticals' APL-1401 shows promising ... Exciting news from Asieris Pharmaceuticals! Our new drug candidate, APL-1401, has shown positive preliminary results in a Phase Ib clinical ...

4. prnewswire.com prnewswire.com/news-releases/asieris-obtained-ind-approval-from-us-fda-for-apl-1401-a-new-drug-for-the-treatment-of-moderately-to-severely-active-ulcerative-colitis-301674213.html

Asieris Obtained IND Approval from US FDA for APL-1401, ... The study is a randomized, double-blind Phase Ib study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL- ...

5. withpower.com withpower.com/trial/phase-1-colitis-1-2023-26362

APL-1401 for Ulcerative Colitis Vedolizumab is significantly more effective than placebo for inducing clinical remission and endoscopic remission in patients with moderate to severe ulcerative ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40222016/

Safety Outcomes in Patients With Ulcerative Colitis Using a ... This large real-world data study found that patients with vs without ulcerative colitis had a higher incidence of most safety outcomes assessed, regardless of ...

7. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05743010/

Trial | NCT05743010 This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 ...