A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01805791
• Date of registration: 04/03/2013
• Prospective Registration: No
• Primary sponsor: Hutchison Medipharma Limited
• Public title: A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis
• Scientific title: A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis
• Date of first enrolment: March 2013
• Target sample size: 201
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01805791
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Rongjun Liu, MD
• Affiliation: Hutchison MediPharma

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must be currently receiving mesalamine = 2.4 g/day (or the equivalent) for at
least 6 weeks prior to randomization and on a stable dosage for at least 2 weeks prior
to entering the screening phase of the study to ensure a stable dose is established at
least 2 weeks prior to the endoscopic procedures.

- Have active mild to moderate ulcerative colitis defined by a modified Mayo Score 4-10,
and with endoscopy score activity of 2-3 points confirmed by centrally read
colonoscopy (within 2 weeks prior to randomization.

- Minimum modified Mayo endoscopy score of >2 at the time of study colonoscopy.

- Age = 18 years.

- Patients have no prior exposure to HMPL-004.

- Have adequate renal, hepatic and bone marrow function (see exclusion criteria).

- All fertile male and female subjects must agree to use one of the following types of
contraception: abstinence, intrauterine device, implantable progesterone device, and
progesterone intramuscular injection, oral contraceptive which has been started at
least one month prior to visit one and continues for the duration of the trial,
contraceptive patch, or condom with spermicide.

- Show evidence of a personally signed and dated informed consent document indicating
that the patient (or legally acceptable representative) has been informed of all
pertinent aspects of the trial

Exclusion Criteria:

1. Subjects with intolerance or adverse reactions to mesalamine (or equivalent
medications).

2. Diagnosed with Crohn's Disease or with lesions such as fistulas or granulomas on
biopsy noted either in history or at baseline endoscope, which would be suspicious for
Crohn's disease, or with a diagnosis of indeterminate colitis. Subjects with Primary
Sclerosing Cholangitis (PSC) are excluded..

3. Severe disease with an ulcerative colitis modified Mayo Clinic score above 10 points
at baseline.

4. Positive stool test for pathogens for sample taken within the previous 2 weeks prior
to study entry.

5. Active Clostridium difficile (C. diff) infection.

6. Use of Inflammatory Bowel Disease related herbal supplements including but not limited
to supplements containing andrographis and probiotics two weeks prior to study entry
or during the study.

7. Toxic megacolon or toxic colitis.

8. Probable requirement for intestinal surgery within 12 weeks after the start of study
medication.

9. Receiving oral or rectal steroids within 1 month prior to study entry.

10. Receiving rectal mesalamine within one week prior to study entry.

11. Receiving azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, cyclosporine, or
other immunosuppressive therapy at the time of screening or within the preceding 6
weeks.

12. Receiving anti-tumor necrosis factor-a agents such as infliximab, adalimumab,
golimumab, or certolizumab pegol at the time of screening or within the preceding 8
weeks.

13. Receiving other investigational drugs or biologics within 1 month or five half lives.

14. Receiving antibiotics within 2 weeks of study entry.

15. Hemoglobin concentration < 9 g/dl.

16. White blood cell count (WBC) below 3,000/cmm, or platelets below 100,000/cmm.

17. Serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate
transaminase (SGPT), alkaline phosphatase >2.5 upper limit of normal.

18. Serum creatinine >1.5 times upper limit of normal.

19. Significant concurrent medical diseases including: active peptic ulcer disease;
uncompensated congestive heart disease; myocardial infarction within the last 12
months; unstable angina pectoris; uncontrolled hypertension; pulmonary disease
requiring oxygen therapy.

20. Chronic Hepatitis B or any history of Hepatitis C.

21. Previous colonic surgery except for simple polypectomy or appendectomy. .

22. History of cancer within the last 5 years other than resected cutaneous basal and
squamous cell carcinomas, and in situ cervical cancer.

23. Patients with a history of or concurrent colonic dysplasia associated with UC, except
those with completely excised sporadic colorectal polyps.

24. Women who are pregnant or breast feeding.

25. Patients known to be seropositive for HIV, or who have had an AIDS defining illness,
or a known immunodeficiency disorder.

26. Patients with a history of tuberculosis or exposure to tuberculosis, or a history of a
chest X-ray suspicious for tuberculosis, unless confirmed to be purified protein
derivative (PPD) skin test negative or latent tuberculosis that has been previously
treated.

27. History of alcohol or drug abuse that would interfere with the ability to be compliant
with the study procedure.

28. Known allergy to plants of the Acanthaceae family.

29. Unwillingness to participate in the study.

30. Any underlying medical condition that in the Investigator's opinion will make the
administration of study drug hazardous to the patient or would obscure the
interpretation of adverse events.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: HMPL-004 2400 mg/day

Drug: Placebo

Drug: HMPL-004 1800 mg/day

Primary Outcome(s)

Percentage of Subjects With a Clinical Remission at Week 8 [Time Frame: 8 weeks]

Secondary Outcome(s)

The Proportion of Subjects With Clinical Response at Week 8 [Time Frame: 8 weeks]

The Proportion of Subjects With Mucosal Healing at Week 8 [Time Frame: 8 weeks]

Secondary ID(s)

HMPL-004-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01805791