| CTRI Number |
CTRI/2021/09/036978 [Registered on: 30/09/2021] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Itolizumab in patients of Systemic Lupus
Erythematosus with or without Active Proliferative Lupus Nephritis.
|
|
Scientific Title of Study
|
A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects with Systemic Lupus with or without Active Proliferative Lupus Nephritis.
|
| Trial Acronym |
EQUALISE |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT04128579 |
ClinicalTrials.gov |
| Version 5.0 dated 03Mar2022 GCT/CT04/FF/2022/35244 |
DCGI |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Supriya Parui |
| Designation |
Senior Regulatory Submissions Coordinator |
| Affiliation |
Medpace Clinical Research India Private Limited |
| Address |
c/o SKP Group B-376
3rd Floor
Nirman Vihar
New Delhi
East
DELHI
110092
India |
| Phone |
9773922367 |
| Fax |
|
| Email |
sparui@medpace.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Surinder Kher |
| Designation |
Clinical and Medical Lead |
| Affiliation |
Vibrance Clinical Research Private Limited |
| Address |
694/1, 25th Cross 9th Main
7th Sector
HSR Layout
Bangalore -560102
Bangalore
KARNATAKA
560102
India |
| Phone |
9900503671 |
| Fax |
|
| Email |
skher@vibranceclinical.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Supriya Parui |
| Designation |
Senior Regulatory Submissions Coordinator |
| Affiliation |
Medpace Clinical Research India Private Limited |
| Address |
c/o SKP Group
B-376
3rd Floor
Nirman Vihar
New Delhi
South
DELHI
110092
India |
| Phone |
9773922367 |
| Fax |
|
| Email |
sparui@medpace.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Equillium Inc |
| Address |
2223 Avenida de la Playa, Suite 108
La Jolla, CA 92037 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Medpace Clinical Research India Pvt Ltd |
c/o SKP Group, B-376, 3rd
Floor, Nirman Vihar
New Delhi - 110092 |
|
|
Countries of Recruitment
|
India
Poland
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreejith Parameswaran |
Jawahar Lal Institute of Post Graduate Medical Education and Research Pondicherry |
Professor, Department of Nephrology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry
Pondicherry
PONDICHERRY |
91-9489148338
sparmeswaran@outlook.com |
| Dr Dinesh Khullar |
Max Super Speciality Hospital |
Chairman, Department of Nephrology, Max Super Speciality Hospital, Saket, New Delhi
New Delhi
DELHI |
91-9810124066
drdineshkhullar@gmail.com |
| Dr Shyam Bihari Bansal |
Medanta - The Medicity Hospital |
Director of Nephrology & Kidney Transplant Medicine
Medanta the Medicity Sector-38, Gurgaon, Haryana
122001
Gurgaon
HARYANA |
91-9810383522
drshyambansal@gmail.com |
| Dr Manish Rathi |
Post Graduate Institute of Medical Education and research ( PGIMER) |
Professor Department of Nephrology, Post Graduate Institute of Medical Education and Research, Madhya Marg, Sector 12, Chandigarh, 160012, Chandigarh, India.
Chandigarh
CHANDIGARH |
01722756734
drmanishrathi2000@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Intervention Studies JIPMER |
Approved |
| Max Healthcare Ethics Committee |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Postgraduate Institute of Medical Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Itolizumab |
Humanized IgG1 kappa immunoglobulin, anti-human CD6. The drug will be given at a dose of 1.6 mg/kg body weight subcutaneously. Each patient will be given 13 doses of the drug every two weeks for a period of 24 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Type A Cohort Key Inclusion Criteria.
1. Is male or female, age ≥ 18 and ≤ 75 years
2. Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE
3. Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently
4. Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening
5. Restricted SLE treatments are stable and/or washed out
6. During Screening, has adequate hematologic function
Type B Cohort Key Inclusion Criteria.
1. Is male or female, age ≥ 18 and ≤ 75 years
2. Meets SLICC and/or ACR criteria for SLE
3. Kidney biopsy with a histologic diagnosis of LN Classes III, IV (+/- V)
4. Has a urine protein to creatinine ratio of > 1000 mg/g
5. Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease
6. During Screening has adequate hematologic function
7. Restricted SLE treatments are stable and/or washed out
8. Most recent eGFR ≥ 40 mL/min/1.73m2
9. Has evidence of serologic activity during Screening
|
|
| ExclusionCriteria |
| Details |
Key Exclusion Criteria:
1. Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
2. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
3. Active TB or a positive TB test
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Treatment Emergent Adverse Events. Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
Type A up to Day 57 or Type B up to Day 253 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EQ001 serum concentrations |
Type A up to Day 57 or Type B up to Day 253 |
| CD6 receptor occupancy. The % levels of free versus EQ001-bound CD6 receptor on T cells |
Type A up to Day 57 or Type B up to Day 253 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
17/12/2021 |
| Date of Study Completion (India) |
19/09/2023 |
| Date of First Enrollment (Global) |
05/11/2019 |
| Date of Study Completion (Global) |
18/01/2024 |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
n |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will enroll up to 50 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of 20 open-label subjects enrolled for Type B-Lupus Nephritis. Subjects will receive itolizumab administered subcutaneously every two weeks for a total of either 2 (Type A) or 13 (Type B) doses with 4 or 12 weeks of follow-up after the last dose of investigational product.
|