A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis

NCT05743010 | Unknown Phase 1 FDA Drug

• 1 other identifier: YHGT-UC-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 in patients with moderately to severely active UC. This study comprises 3 periods including screening period (D-28\~D-1), treatment period (D1-D28), and safety follow-up period(D29-D58).

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• Number of Participants adverse events (AEs)

  An AE was defined as any untoward and unintended medical experience (sign, symptom, appearance of new illness or deterioration of pre-existed disease, abnormal laboratory finding or other medical event) in a patient from obtaining informed consent form, but which did not necessarily have a causal relationship with the study intervention. Incidence of serious adverse events (SAEs) Incidence of adverse events leading to investigational drug discontinuation Incidence of adverse events of special interest (AESI) Laboratory evaluation results Vital sign measurements Physical examination findings

  Up to 30 days after the last dose

• Number of Participants serious adverse events (SAEs)

  An SAE is defined as any untoward medical occurrence that, at any dose, including results in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, a congenital anomaly/birth defect, other situations.

  Up to 30 days after the last dose

• Number of Participants adverse events of special interest (AESI)

  An adverse event of special interest (AESI) is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor is required, including rash, orthostatic hypotension, thyroid dysfunction.

  Up to 30 days after the last dose

Secondary Outcomes (14)

• Cmax

  Day 1 through Day 28

• Tmax

  Day 1 through Day 28

• T1/2

  Day 1 through Day 28

• AUClast

  Day 1 through Day 28

• AUC0-24

  Day 1 through Day 28

Other Outcomes (4)

• CRP

  Day 1 through Day 28

• ESR

  Day 1 through Day 28

• Fecal lactoferrin

  Day 1 through Day 28

Study Arms (2)

APL-1401

EXPERIMENTAL

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.

Drug: APL-1401

Placebo

PLACEBO COMPARATOR

Identically matching placebo capsules once daily for 28 days

Drug: Placebo

Interventions

APL-1401 DRUG

APL-1401 capsules orally once daily

Also known as: Nepicastat, SYN117

APL-1401

Placebo DRUG

Placebo capsules orally once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent.
• Age 18-65 years (inclusive).
• With a history of UC diagnosis at least 3 months prior to screening.
• Currently has active UC, defined as a Total Mayo Score of 6 to 12 (inclusive), at baseline, and with a Mayo Endoscopic Sub-Score (MESS) ≥ 2 confirmed by a site reader.
• Has a rectal bleeding score ≥1 and a stool frequency Score ≥1 and in addition to MESS ≥2 during screening.
• May be receiving the following drugs:
• Oral 5-ammosahcylate (5-ASA) class of medications (mesalamine, olsalazine, balsalazide, sulfasalazine), provided the prescribed dose has been stable for at least 4 weeks prior to randomization; dose must be stable during the treatment period.
• Oral corticosteroid therapy (prednisone prescribed at a stable dose ≤ 30 mg/day or budesonide prescribed at a stable dose of ≤ 9 mg/day), provided the prescribed dose has been stable for at least 2 weeks prior to randomization; during the treatment period, the same dose should be maintained but can be tapered by the investigators.
• Women of childbearing potential must have a negative pregnancy test at screening visit and agree to use 2 highly effective methods of birth control at the same time during entire study period.
• Male subjects must agree to use protocol specified method(s) of contraception from screening visit until 3 months after last dose.

You may not qualify if:

• Has fulminant colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's disease, history of colitis-associated colonic dysplasia, active peptic ulcer disease.
• Has a current clinically significant bacterial, parasitic, fungal, or viral infection.
• Is positive for hepatitis A, B or C, human immunodeficiency virus (HIV), or tuberculosis.
• Uses any of the following medications:
• Intravenous corticosteroids 1 week prior to randomization;
• Topical 5-ASA compounds or topical steroid (i.e., enemas or suppositories) 2 weeks prior to randomization;
• Anti-diarrheal medications 2 weeks prior to randomization;
• Sphingosine 1-phosphate receptor (S1PR) modulator including ozanimod 9 prior to randomization;
• JAK inhibitors including tofacitinib and upadacitinib 4 weeks prior to randomization;
• TNF-α antagonist including (but not limited to) infliximab, adalimumab, golimumab, certolizumab, or biosimilar agents 10 weeks prior to randomization;
• Integrin antagonist, including vedolizumab 18 weeks prior to screening and natalizumab 10 weeks prior to screening;
• Interleukin antagonist including ustekinumab 14 weeks prior to screening;
• Patients receiving any of the following medications, if they were not discontinued at least 2 weeks prior to randomization: azathioprine, 6-mercaptopurine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, thalidomide. See Table 1;
• Prohibited concomitant medications as described in Section 6.5.2 Table 1.
• Participated in another clinical study of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another study of an investigational drug (or medical device).

Sponsors & Collaborators

• Jiangsu Yahong Meditech Co., Ltd aka Asieris: lead

Study Sites (4)

New Hope Research Development

Corona, California, 92882, United States

RECRUITING

Guardian Angel Research Center

Tampa, Florida, 33614, United States

RECRUITING

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

RECRUITING

Meridian Clinical Research

Rockville, Maryland, 20854, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

nepicastat

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Qiuyue QU

  Jiangsu Yahong Meditech Co., Ltd aka Asieris

  STUDY DIRECTOR

Central Study Contacts

Qiuyue QU

CONTACT

+86 021 68583863; qyqu@asieris.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: February 24, 2023
• Study Start: January 26, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)