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NCT Number: NCT03677648

A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 26 weeks.

With the wealth of scientific evidence on JAK/STAT involvement in IBD, the data from similar class of new drugs and the current data on SHR0302 (JAK1 inhibitor), support the rationale to proceed with phase II studies to evaluate the efficacy and safety of SHR0302 in patients with moderate to severe active CD.

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Key information

Conditions

Crohn's Disease Crohn Disease 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

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and Female subject at ≥18 and ≤ 75 years of age at randomization.
  • Subjects with a documented three-month history of diagnosed ileal, colonic, or ileocolonic Crohn's Disease at the time of randomization.
  • Currently having Crohn's Disease with Crohn's Disease Activity Index (CDAI) score ≥ 220 to ≤450.

Exclusion criteria

  • Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
  • Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
  • Treatment naïve subjects diagnosed with Crohn's disease, (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 JAK inhibitor).

Placebos

Drug

Placebos

Primary outcomes

  1. The percentage of subjects achieving clinical remission at week 12.

    Time frame: week12

    The percentage of subjects achieving clinical remission at week 12, defined as Crohn's Disease Activity Index (CDAI) score < 150.

Secondary outcomes

  1. The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.

    Time frame: week 1, 4, 8, 12, 13, 16, and 24

    The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.

  2. The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.

    Time frame: week 1, 4, 8, 12, 13, 16, and 24

    The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.

  3. The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.

    Time frame: week 1, 4, 8, 12, 13, 16, and 24

    The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.

Sponsors and collaborators

Lead sponsor

Reistone Biopharma Company Limited

Industry

Registry information

Official study title

A Phase II Randomized, Placebo Controlled, Double-blind, Four Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Crohn's Disease

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2018
Registry last updated
Mar 15, 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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