A Study of Ustekinumab in Indian Participants with Crohn’s Disease

• Register: CTRI
• Last refreshed on: 29 April 2024
• Main ID: CTRI/2023/11/059689
• Date of registration: 08-11-2023
• Prospective Registration: Yes
• Primary sponsor: Johnson and Johnson Private Limited
• Public title: A Study of Ustekinumab in Indian Participants with Crohn’s Disease
• Scientific title: An Open Label, Multicentre, Phase IV Study of Ustekinumab to Evaluate Its Safety in Indian Subjects with Crohn’s Disease (CD) - NIL
• Date of first enrolment: 24-11-2023
• Target sample size: 80
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=89076
• Study type: Interventional
• Study design: Single Arm Study Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Dr Sanish Davis
• Affiliation: Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd

• Name: Dr Sanish Davis
• Affiliation: Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1)Adult subjects who are diagnosed as Crohn’s disease for at least 3 months with moderate to severe disease based on CDAI score of 220-450 at baseline

2) Subject should have either failed or were intolerant to immunomodulators or corticosteroids, or were corticosteroid dependent, or have failed, or were intolerant to one or more biological treatments. Subjects who were receiving the above should have received continuous therapy for adequate duration at the highest recommended doses or should have been unable to receive the full course of full-dose therapy because of intolerance, toxicity, or contraindications

3) Women of childbearing potential or men capable of fathering children must be using highly effective birth control measures during the study and must be willing to use such birth control measures. Donation of ova, oocytes, or sperm for the purpose of assisted reproduction during the study and for a period of 16 weeks after the last administration of study interventions are prohibited. Female subjects of childbearing potential must test negative for pregnancy by HCG at screening visit.

4) Are considered eligible per the following tuberculosis (TB) screening criteria:

a. Have no history of TB prior to screening.

AND

b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.

AND

c. Have had no recent close contact with a person with active TB, or if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study drug.

AND

d. Within 6 weeks prior to the first administration of study drug, have a negative QuantiFERON- TB Gold and a negative tuberculin skin test result, OR have a newly identified positive QuantiFERON-TB Gold or tuberculin skin test result during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study drug. A subject whose first QuantiFERON-TB test result is indeterminate should have the test repeated. In the event that additional QuantiFERON-TB test result is persistently indeterminate, the subject should also initiate treatment for latent TB in order to enter the study.

AND

e. Have a chest radiograph (both Postero-anterior and lateral views), taken within 3 months prior to the first administration of study drug and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.

5) Have screening laboratory test results as follows:

a. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level not exceeding 2.0 times the ULN for the laboratory conducting the test.

b. Serum creatinine not exceeding 1.7 mg/dL

6) It is recommended that subjects are up to date on age-appropriate vaccinations prior to screening as per routine local medical guidelines. For study subjects who received locally approved (and including emergency use-authorized) COVID-19 vaccines recently prior to study entry, follow applicable local vaccine labelling, guidelines, and standards of care for subjects receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrolment.
Exclusion criteria: 1. Has a history of treatment with interleukin-12 and/or interleukin-23 antagonists.

2. Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab

3. Has stool culture or other examination positive for an enteric pathogen (done at the discretion of the Principal Investigator), including Clostridium difficile toxin, in previous 4 months, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.

4. Has a history of latent or active granulomatous infection prior to screening. Anyother active or latent granulomatous infections (including active tuberculosis [TB]) will be excluded.

5. Had a serious infection (including but not limited to, hepatitis, pneumonia, abscess, sepsis, or pyelonephritis), or have been hospitalized for an infection, or have been treated with IV antibiotics for an infection within 2 months prior to first administration of study drug. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and no abscesses are currently identified. Less serious infections (e.g., acute upper respiratory tract infection, simple urinary tract infection, simple gastrointestinal infection) need not be considered exclusionary at the discretion of the investigator.

6. Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic nonremitting cystitis), an open, draining, or infected skin wound, or an ulcer.

7. Are currently infected (including carriers) with Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). For subjects who are not

eligible for this study due to HIV, HCV, or HBV test results, consultation with a physician with expertise in the treatment of those infections is recommended.

8. Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening) or a history of lymphoproliferative disease

9. Are pregnant, breastfeeding, or planning a pregnancy or fathering a child during the study or within 6 months after receiving the last administration of study drug.

10. Has a known clinically significant hypersensitivity to ustekinumab or to any of the excipients.

11. Has been treated with any investigational drug in last 6 months prior to the first administration of study drug

12. Has received, or are expected to receive, any live virus or bacterial vaccination within 3 months before the first administra

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: K509- Crohns disease, unspecified

Intervention(s)

Intervention1: Ustekinumab (Stelara™): 130 mg Ustekinumab will be
administered intravenously at week 0 and Subsequent
dosing of 90 mg subcutaneously from week 8 to Week 24 (every 8 weeks).
Intervention2: Ustekinumab (Stelara™) S.C.
: S.C. Dose; 90 mg
Subsequent dosing SC (8 weekly) – 1 vial (90mg)
Control Intervention1: No applicable: No applicable

Primary Outcome(s)

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)Timepoint: over 38 weeks

Secondary Outcome(s)

Percentage of subjects with clinical remission defined by Crohns Disease Activity Index (CDAI) score less than 150Timepoint: at Week 8, at Week 16 & at Week 24

Percentage of subjects with clinical response defined by decrease of 100 or more on the CDAI score or a total CDAI score less than 150Timepoint: at Week 8, at Week 16 & at Week 24

Secondary ID(s)

CNTO1275CRD4045, dated 03 Oct 2022

Source(s) of Monetary Support

Johnson and Johnson Private Limited Arena Space Jogeshwari East Mumbai MAHARASHTRA

Ethics review

Status: Approved
Approval date: 31/07/2023
Contact:

Surat Institute of Digestive Sciences Ethics Committee

Status: Approved
Approval date: 05/09/2023
Contact:

S.R.Kalla Memorial Ethical Committee for Human Research

Status: Approved
Approval date: 19/09/2023
Contact:

Institute Ethics Committee; All India lnstitute of Medical Sciences

Status: Approved
Approval date: 21/09/2023
Contact:

Institutional Ethics Committee, Fortis Memorial Research Institute

Status: Approved
Approval date: 12/10/2023
Contact:

Institutional Ethics Committee;Indira Gandhi Institute of Medical Sciences

Status: Approved
Approval date: 06/11/2023
Contact:

Institutional Ethics Committee, Institute of Medical Sciences

Status: Approved
Approval date: 27/11/2023
Contact:

Institutional Ethics Committee- SRM Institutes for Medical science

Status: Approved
Approval date: 27/11/2023
Contact:

Institutional Ethics Committee, Asian Institute of Gastroenterology

Status: Approved
Approval date: 17/01/2024
Contact:

Institutional Ethics Committee;Fortis Hospital

Status: Approved
Approval date: 02/04/2024
Contact:

Human Ethics Committee Government Medical College

Status: Approved
Approval date: 02/04/2024
Contact:

Institutional Ethics Committee, Maulana Azad Medical College

Status: Not Approved
Approval date:
Contact:

Drug Trials Ethics Committee