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NCT Number: NCT03675477

A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time needed to induce clinical response in active ulcerative colitis patients.

This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. Early withdrawn subjects during the first treatment phase can not enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18 weeks.

SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation. Therefore it has the potential to be a treatment for ulcerative colitis.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female subject age ≥ 18 and ≤75 years of age at randomization.
  • Active ulcerative colitis with a 9-point modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (The duration of the time between endoscopy and baseline should not exceed 10 days and allow central over read turn over before randomization).
  • Subject should have at least three-month history of Ulcerative Colitis diagnosis at randomization.

Exclusion criteria

  • Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
  • Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).
  • Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).

Treatment and study plan

SHR0302

Drug

The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a Janus kinase inhibitor).

Other names: Ivarmacitinib

Placebo

Drug

Placebo Oral Tablet

Primary outcomes

  1. The Percentage of Subject Achieve Clinical Response at Week 8

    Time frame: Week 8

    Clinical response is defined as a decrease from baseline in a 9-point modified Mayo score of at least 2 points and at least 30%, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.

    The 9-point modified Mayo score is the Mayo score excluding the Physician Global Assessment sub-score, hence the maximum is 9 points and the minimum is 0 point, includes:

    Stool Frequency 0 = Normal

    • = 1-2 stools/day more than normal
    • = 3-4 stools/day more than normal
    • = 5 or more stools/day than normal

    Rectal bleeding 0 = None

    • = Visible blood with stool less than half the time
    • = Visible blood with stool half of the time or more
    • = Passing blood alone

    Mucosal appearance at endoscopy 0 = Normal or inactive disease

    • = Mild disease (erythema, decreased vascular pattern, mild friability
    • = Moderate disease (marked erythema, absent vascular pattern, friability, erosio

Secondary outcomes

  1. The Percentage of Subjects Achieve Clinical Remission

    Time frame: Week 8

    Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point. The percentage of subjects who achieve clinical remission per 9-point modified Mayo score at week 8, where stool frequency subscore ≤ 1, rectal bleeding subscore of 0, and endoscopic subscore ≤ 1.

    9-point modified Mayo score includes: Stool Frequency 0 = Normal

    • = 1-2 stools/day more than normal
    • = 3-4 stools/day more than normal
    • = 5 or more stools/day than normal

    Rectal bleeding 0 = None

    • = Visible blood with stool less than half the time
    • = Visible blood with stool half of the time or more
    • = Passing blood alone

    Mucosal appearance at endoscopy 0 = Normal or inactive disease

    • = Mild disease (erythema, decreased vascular pattern, mild friability
    • = Moderate disease (marked erythema, absent vascular pattern, friability, erosions)
    • = Severe disease (spontaneous bleeding, ulceration)

  2. The Percentage of Subjects Achieve Clinical Remission at Week 8

    Time frame: Week 8

    Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point. The percentage of subjects achieve clinical remission at week 8 as per a total Mayo score of 2 points or lower ≤2, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.

    The 9-point modified Mayo score includes:

    Stool Frequency 0 = Normal

    • = 1-2 stools/day more than normal
    • = 3-4 stools/day more than normal
    • = 5 or more stools/day than normal

    Rectal bleeding 0 = None

    • = Visible blood with stool less than half the time
    • = Visible blood with stool half of the time or more
    • = Passing blood alone

    Mucosal appearance at endoscopy 0 = Normal or inactive disease

    • = Mild disease (erythema, decreased vascular pattern, mild friability
    • = Moderate disease (marked erythema, absent vascular patt

  3. The Percentage of Subjects Achieve Endoscopic Remission (Mucosal Healing) at Week 8

    Time frame: Week 8

    Endoscopic remission was defined by Mayo endoscopic subscore ≤ 1 point. Mayo endoscopic subscore defines score 0 as normal or inactive disease, score 1 as mild disease (erythema, decreased vascular pattern, mild friability); score 2 as moderate disease (marked erythema, absent vascular pattern, friability, erosions)； score 3 as severe disease (spontaneous bleeding, ulceration).

Sponsors and collaborators

Lead sponsor

Reistone Biopharma Company Limited

Industry

Registry information

Official study title

A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis.

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 18, 2018
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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