Ulcerative ColitisPhase 2NCT00659802

Phase II Study of HMPL-004 in Patients With Ulcerative Colitis

A Phase 2 study testing HMPL-004 low dose and HMPL-004 high dose in people with Ulcerative Colitis, run by Hutchison Medipharma Limited.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ulcerative Colitis
What is being tested?: HMPL-004 low dose and HMPL-004 high dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 224 participants
Where: No sites listed yet
Study dates: 7 Feb 2008to 13 Oct 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have active confirmed mild to moderate ulcerative colitis

Who cannot join

Diagnosed with Crohn's Disease or

About this study

Official title: A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine

The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.

Read the detailed description

This is a double-blind, randomized, placebo-controlled Phase II study conducted in North America (U.S. and Canada) and Europe (Romania and Ukraine) in patients with mild to moderate ulcerative colitis. Treatment consisted of one of 2 doses of HMPL-004 (1200 mg daily or 1800 mg daily, administered in 3 divided doses) or matching placebo. Assessment of treatment effect is based on the Mayo score. Subjects eligible for the study will include those ≥18 years of age with mild to moderate ulcerative colitis, having a Mayo score of 4 to 10, with activity confirmed by endoscopy within 2 weeks prior to study entry, and having a Mayo endoscopy score ≥1. Subjects who are using concomitant mesalamine could enter the study. The randomization will be stratified by mesalamine use or non-use.

Conditions: Ulcerative Colitis
Being tested: HMPL-004 low dose, Placebo, HMPL-004 high dose
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HMPL-004 low doseDrug
Also called Chuan xinlian
HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
PlaceboDrug
Matching dose of Placebo
HMPL-004 high doseDrug
Also called Chuan xinlian
HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).

Study groups in NCT00659802
Study group	Role	What they receive
placebo	Placebo comparator	Matching dose of placebo will be given orally in capsules three times per day for 56 days. Receives: Drug: Placebo
HMPL-004 low dose	Experimental	A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. Receives: Drug: HMPL-004 low dose
HMPL-004 high dose	Experimental	A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. Receives: Drug: HMPL-004 high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Clinical Response at Week 8
Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1.
The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.
Measured: 8 weeks

Secondary outcomes (2)

Number of Participants With a Clinical Remission at Week 8
The percentage of subjects exhibiting clinical remission (Mayo score ≤2 with no individual score >1) at week 8.
The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.
Measured: 8 weeks
Number of Participants With Mucosal Healing at Week 8
The percentage of subjects achieving Mucosal Healing at week 8. Mucosal Healing was defined as a significant decrease from baseline in the Mayo endoscopy sub-score ≥1 and absolute score ≤1. Mayo endoscopy sub-score ranges from 0 to 12. The higher score means a higher disease activity or worse outcome.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 200813 Oct 2009

First posted16 Apr 2008 (estimated)
Study start7 Feb 2008
Primary completion13 Oct 2009
Study completion13 Oct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00659802
Sponsor's protocol ID: HMPL-004-US-02
Status last verified: Jul 2020
First submitted: 8 Apr 2008
Last updated: 22 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine
ClinicalTrials.gov ID: NCT00659802
Acronym / sponsor ID: HMPL-004-US-02
Conditions: Ulcerative Colitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
Study start: 7 Feb 2008 (actual)
Primary completion: 13 Oct 2009 (actual)
Study completion: 13 Oct 2009 (actual)
First posted: 16 Apr 2008 (estimated)
Results: Posted 22 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
placebo	Placebo comparator	Drug: PlaceboMatching dose of placebo will be given orally in capsules three times per day for 56 days.
HMPL-004 low dose	Experimental	Drug: HMPL-004 low doseA total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.
HMPL-004 high dose	Experimental	Drug: HMPL-004 high doseA total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Have active confirmed mild to moderate ulcerative colitis

Key exclusion criteria (1 listed)

Diagnosed with Crohn's Disease or

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HMPL-004 low doseAlso: Chuan xinlianHMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).	Drug	HMPL-004 low dose
PlaceboMatching dose of Placebo	Drug	placebo
HMPL-004 high doseAlso: Chuan xinlianHMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).	Drug	HMPL-004 high dose

Primary outcome

Number of Participants With a Clinical Response at Week 8
Time frame: 8 weeks
Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1. The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.

2 secondary outcomes

Number of Participants With a Clinical Remission at Week 8
Time frame: 8 weeks
Number of Participants With Mucosal Healing at Week 8
Time frame: 8 weeks

Results and safety

Results posted to the registry on 22 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Dose HMPL-004 (1800 mg/Day)	74	59
Low Dose HMPL-004 (1200 mg/Day)	75	57
Placebo	75	64

Primary outcome: Number of Participants With a Clinical Response at Week 8

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Low Dose HMPL-004 (1200 mg/Day) n = 60	High Dose HMPL-004 (1800 mg/Day) n = 62	Placebo n = 69
Value	33	45	30

Population analysed: Based on number of subjects with a non-missing value in each treatment group.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 2.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose HMPL-004 (1200 mg/Day)	2 of 75 (2.7%)	45 of 75 (60%)	0 of 75
High Dose HMPL-004 (1800 mg/Day)	2 of 74 (2.7%)	39 of 74 (52.7%)	0 of 74
Placebo	2 of 75 (2.7%)	45 of 75 (60%)	0 of 75

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HMPL-004 low dose and HMPL-004 high dose in people with Ulcerative Colitis, run by Hutchison Medipharma Limited.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Clinical Response at Week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00659802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.