To Evaluate the Efficacy and Safety of Sirolimus for Crohn's Disease With Stenosis

Study Purpose

Crohn's disease (CD) with stenosis has limited therapeutic options and with high surgical rate. The present clinical trial aims to evaluate the efficacy and safety of sirolimus in the treatment of stricturing Crohn's Disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - moderate to severe Crohn's Disease (basic HBI ≥ 7) with stenosis

    Exclusion Criteria:

    - Allergic to sirolimus or serious side effects - Need emergency surgery - Accompanied with other severe disease (involve C.
diff infection) - Follow-up less than 1 year

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The Second Hospital of Nanjing Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Faming Zhang, MD,PhD
Principal Investigator Affiliation Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Diseases
Additional Details

Management of Crohn's disease (CD) with stenosis is challenging and often requires endoscopic dilatation or surgical resection of the strictured bowel. Sirolimus (rapamycin), a macrocyclic antibiotic with immunosuppressive and antineoplastic properties, has been reported as promising rescue therapy for refractory CD. This study aims to evaluate the use of sirolimus for stricturing Crohn's Disease. Patients in this study will receive a continuous dosing schedule of oral sirolimus 2mg daily for six months and follow-up for at least one year. The Harvey-Bradshaw Index (HBI) score, Blood tests , MRI and endoscopy will be used to assess participants at study start and at follow-up points.

Arms & Interventions


Experimental: Sirolimus

Subjects receive a continuous dosing schedule of oral sirolimus 2mg daily for six months and follow-up for at least one year.


Drug: - Sirolimus

Sirolimus 2mg daily will be given to subjects by oral for six months.

Drug: - 5-ASA, Prednisone, Azathioprine or Remicade

5-ASA, Prednisone, Azathioprine and Remicade are traditional treatments according to associated guidelines

Contact a Trial Team

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International Sites

Nanjing, Jiangsu, China




Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011

Site Contact

Faming Zhang, MD, PhD


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