## Protocol Section
### Identification Module
**NCT ID:** NCT04128579

**Acronym:** EQUALISE

**Brief Title:** Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis

**Official Title:** A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis

#### Organization Study ID Info
**ID:** EQ001-19-002
#### Organization
**Class:** INDUSTRY
**Full Name:** Equillium
### Status Module
#### Completion Date
**Date:** 2024-01-18

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-16

**Type:** ACTUAL

#### Start Date
**Date:** 2019-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2019-10-16
**Type:** ACTUAL
**Study First Submit Date:** 2019-09-30
**Study First Submit QC Date:** 2019-10-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Biocon Limited

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Equillium

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis

**Detailed Description:** The study will enroll approximately 55 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of approximately 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.

### Conditions Module

**Conditions:**

- Lupus Erythematosus

- Lupus Nephritis

**Keywords:**

- Systemic Lupus Erythematosus

- Active Proliferative Lupus Nephritis

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SEQUENTIAL

**Intervention Model Description:** cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B)

##### Masking Info

**Masking:** NONE

**Masking Description:** Type A and Type B are open-label.

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 55

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses (up to 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg).

**Intervention Names:**

- Drug: Itolizumab [Bmab 600]

**Label:** EQ001 Type A cohort

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).

**Intervention Names:**

- Drug: Itolizumab [Bmab 600]

**Label:** EQ001 for Type B cohort

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- EQ001 Type A cohort

- EQ001 for Type B cohort

**Description:** EQ001

**Name:** Itolizumab [Bmab 600]

**Other Names:**

- Bmab600

- Itolizumab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

**Measure:** Incidence of Treatment Emergent Adverse Events

**Time Frame:** Type A up to Day 57 or Type B up to Day 253

#### Secondary Outcomes

**Description:** To characterize the pharmacokinetics of itolizumab

**Measure:** To characterize the PK of itolizumab

**Time Frame:** Type A up to Day 57 or Type B up to Day 253

**Description:** the % levels of free versus EQ001-bound CD6 receptor on T cells

**Measure:** CD6 receptor occupancy

**Time Frame:** Type A up to Day 57 or Type B up to Day 253

### Eligibility Module

**Eligibility Criteria:** 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. Has a diagnosis of SLE
3. Kidney biopsy with a histologic diagnosis of LN Classes III or 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 or has an incomplete response to current treatment
6. 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

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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sun City

**Country:** United States

**Facility:** AKDHC Medical Research Services, LLC

**State:** Arizona

**Zip:** 85351

**Location 2:**

**City:** Chula Vista

**Country:** United States

**Facility:** California Institute of Renal Research

**State:** California

**Zip:** 91910

**Location 3:**

**City:** La Jolla

**Country:** United States

**Facility:** University of California San Diego Perlman Ambulatory Clinic

**State:** California

**Zip:** 92037

**Location 4:**

**City:** Clearwater

**Country:** United States

**Facility:** Clinical Research of West Florida - Clearwater

**State:** Florida

**Zip:** 33765-2616

**Location 5:**

**City:** Fort Lauderdale

**Country:** United States

**Facility:** Centre for Rheumatology, Immunology and Arthritis

**State:** Florida

**Zip:** 33309

**Location 6:**

**City:** Gainesville

**Country:** United States

**Facility:** University of Florida, Division of Rheumatology

**State:** Florida

**Zip:** 32610

**Location 7:**

**City:** Leesburg

**Country:** United States

**Facility:** Clinical Site Partners Leesburg, LLC

**State:** Florida

**Zip:** 34748

**Location 8:**

**City:** Miami

**Country:** United States

**Facility:** SouthCoast Research Center Inc

**State:** Florida

**Zip:** 33136

**Location 9:**

**City:** Miami

**Country:** United States

**Facility:** Hope Clinical Trials

**State:** Florida

**Zip:** 33165

**Location 10:**

**City:** Orlando

**Country:** United States

**Facility:** Omega Research Maitland, LLC

**State:** Florida

**Zip:** 32810

**Location 11:**

**City:** Tampa

**Country:** United States

**Facility:** Clinical Research of West Florida - Tampa

**State:** Florida

**Zip:** 33603

**Location 12:**

**City:** Tampa

**Country:** United States

**Facility:** University of South Florida

**State:** Florida

**Zip:** 33606

**Location 13:**

**City:** Lawrenceville

**Country:** United States

**Facility:** Georgia Nephrology

**State:** Georgia

**Zip:** 30046

**Location 14:**

**City:** Bronx

**Country:** United States

**Facility:** Albert Einstein College of Medicine, Montefiore Medical Center

**State:** New York

**Zip:** 10461

**Location 15:**

**City:** Great Neck

**Country:** United States

**Facility:** Northwell Health / Division of Rheumatology

**State:** New York

**Zip:** 11021

**Location 16:**

**City:** New York

**Country:** United States

**Facility:** Columbia University Medical Center, Div of Nephrology

**State:** New York

**Zip:** 10032

**Location 17:**

**City:** Bethlehem

**Country:** United States

**Facility:** Northeast Clinical Research Center, LLC

**State:** Pennsylvania

**Zip:** 18017

**Location 18:**

**City:** Dallas

**Country:** United States

**Facility:** Dallas Renal Group

**State:** Texas

**Zip:** 75230

**Location 19:**

**City:** Houston

**Country:** United States

**Facility:** Prolato Clinical Research Center (PCRC)

**State:** Texas

**Zip:** 77054

**Location 20:**

**City:** Chandigarh

**Country:** India

**Facility:** Post Graduate Institute of Medical Education and Research (PGIMER)

**Location 21:**

**City:** Gurugramam

**Country:** India

**Facility:** Medanta - The Medicity Hospital

**Location 22:**

**City:** New Delhi

**Country:** India

**Facility:** MAX Super Specialty Hospital

**Location 23:**

**City:** Puducherry

**Country:** India

**Facility:** Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)

**Location 24:**

**City:** Warszawa

**Country:** Poland

**Facility:** Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ

**Zip:** 04-749

**Location 25:**

**City:** Łódź

**Country:** Poland

**Facility:** SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii

**Zip:** 92-213

#### Overall Officials

**Official 1:**

**Affiliation:** UCSD

**Name:** Kenneth Kalunian, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** company website

**URL:** https://equilliumbio.com/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000005921

- Term: Glomerulonephritis

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12338

- Name: Nephritis

- Relevance: HIGH

- As Found: Nephritis

- ID: M11178

- Name: Lupus Nephritis

- Relevance: HIGH

- As Found: Lupus Nephritis

- ID: M11177

- Name: Lupus Erythematosus, Systemic

- Relevance: HIGH

- As Found: Systemic Lupus Erythematosus

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9031

- Name: Glomerulonephritis

- Relevance: LOW

- As Found: Unknown

- ID: T3523

- Name: Lupus Nephritis

- Relevance: HIGH

- As Found: Lupus Nephritis

- ID: T2525

- Name: Glomerulonephritis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009393

- Term: Nephritis

- ID: D000008181

- Term: Lupus Nephritis

- ID: D000008180

- Term: Lupus Erythematosus, Systemic

### Misc Info Module

- Version Holder: 2024-05-24
