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

Trial Summary

What is the purpose of this trial?

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.

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.

What makes the drug APL-1401 unique for treating ulcerative colitis?

The research does not provide specific information about APL-1401, so its unique aspects compared to existing treatments for ulcerative colitis are not detailed. ^{1 2 3 4 5}

Research Team

Qiuyue QU

Principal Investigator

Jiangsu Yahong Meditech Co., Ltd aka Asieris

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 65 years old.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Golimumab for moderately to severely active ulcerative colitis. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Vedolizumab for induction and maintenance of remission in ulcerative colitis. [2018]

4. England pubmed.ncbi.nlm.nih.gov

The biologics of ulcerative colitis. [2018]

5. England 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. [2019]