36 Participants Needed

APL-1401 for Ulcerative Colitis

Recruiting in Rockville (>99 mi)
+5 other locations
QQ
Overseen ByQiuyue QU
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Jiangsu Yahong Meditech Co., Ltd aka Asieris
Must be taking: Oral 5-ASA, Corticosteroids
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

QQ

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.
See 1 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: APL-1401Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as APL-1401 for:
🇨🇳
Approved in China as APL-1401 for:

Find a Clinic Near You

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

Citations

Emerging drugs for the treatment of moderately to severely active ulcerative colitis: review of phase II and III clinical trials. [2023]
Golimumab for moderately to severely active ulcerative colitis. [2017]
Vedolizumab for induction and maintenance of remission in ulcerative colitis. [2018]
The biologics of ulcerative colitis. [2018]
Clinical outcome of adalimumab therapy in patients with ulcerative colitis previously treated with infliximab: a Danish single-center cohort study. [2019]
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