Phase 3 clinical study designed to evaluate the efficacy and safety in patients.

Phase 3

Completed

• Conditions: Crohns disease of small intestine,

• Registration Number: CTRI/2020/10/028507
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn’s disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-27
• Study Completion: 2023-02-10
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Diagnosis of CD for at least 3 months prior to baseline.
• Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD 3.
• Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD 4.
• If female, subject must meet the contraception recommendations.

Exclusion Criteria

• Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome 2.
• Currently have or are suspected to have an abscess.
• Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery 3.
• Have a stoma, ileoanal pouch or ostomy 4.
• Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline 5.
• Have ever received any monoclonal antibodies binding IL-23.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Endoscopic Response	Week 52
Percentage of Participants Achieving Clinical Remission	Week 52

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Endoscopic Remission.	Percentage of Participants Achieving Clinical Remission or Endoscopic Remission who were Corticosteroid Free.
Percentage of Participants Achieving Clinical Remission	Week 12
Percentage of Participants Achieving Clinical Remission.
Change from Baseline in C-Reactive Protein.	Change from Baseline in Fecal Calprotectin.
Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohns Disease.	Percentage of Participants with Fistulae Response.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab	Baseline through Week 52
Change from Baseline in Health Related Quality of Life	Baseline, Week 52

Trial Locations

Locations (14)

Aakash Healthcare Superspeciality Hospital; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences (AIIMS); 🇮🇳 Delhi, DELHI, India

Apollo Speciality Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Asia Institute of Gastroenterology; 🇮🇳 Hyderabad, TELANGANA, India

Dayanand Medical College & Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Gandhi Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Gujarat Hospital - Gastro and Vascular Centre; 🇮🇳 Surat, GUJARAT, India

International Gastro Institute; 🇮🇳 Vadodara, GUJARAT, India

Midas institute of Gastroenterology; 🇮🇳 Nagpur, MAHARASHTRA, India

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Scroll for more (4 remaining)

Aakash Healthcare Superspeciality Hospital

🇮🇳Delhi, DELHI, India

Dr Sharad Malhotra

Principal investigator

9810161287

sharaddoctor@gmail.com