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Trial record 1 of 1 for:    NCT03763318
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A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD (EQUATE)

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ClinicalTrials.gov Identifier: NCT03763318
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Biocon Limited
Information provided by (Responsible Party):
Equillium

Tracking Information
First Submitted Date  ICMJE November 19, 2018
First Posted Date  ICMJE December 4, 2018
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • Incidence of Treatment Emergent Adverse Events [ Time Frame: Study Day 85 ]
    Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
  • Change from baseline in aGVHD organ stages and overall clinical grading, aGVHD-AI [ Time Frame: Study Day 337 ]
    Clinical activity will be assessed by change from baseline in aGVHD organ stages and overall clinical grading, aGVHD-AI, concomitant medication usage and disease progression assessments
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03763318 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • Time to maximum EQ001serum concentration, Tmax [ Time Frame: Study Day 337 ]
    Time to maximum EQ001 serum concentration, Tmax
  • Maximum EQ001 serum drug concentration, Cmax [ Time Frame: Study Day 337 ]
    Maximum EQ001 serum drug concentration, Cmax
  • Minimum EQ001 serum drug concentration, Cmin [ Time Frame: Study Day 337 ]
    Minimum EQ001 serum drug concentration prior to next dose, Cmin
  • Total EQ001 exposure across time, AUC (from zero to infinity) [ Time Frame: Study Day 337 ]
    Total EQ001 exposure across time, AUC (from zero to infinity)
  • Half life of EQ001, t1/2 [ Time Frame: Study Day 337 ]
    Half life of EQ001, t1/2
  • Volume of distribution of EQ001, Vd [ Time Frame: Study Day 337 ]
    Volume of distribution of EQ001, Vd
  • Clearance, Cl [ Time Frame: Study Day 337 ]
    Clearance, Cl
  • Inflammatory Markers [ Time Frame: Study Day 337 ]
    Including but not limited to: IL-1β, IL-2, IL-6, IL-17, IL-21, IL-22, IL-23, IFN-γ, and TGF-β, C-reactive protein
  • CD6 receptor occupancy [ Time Frame: Study Day 337 ]
    CD6 receptor occupancy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
Official Title  ICMJE A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of EQ001 in Subjects With Newly Diagnosed Acute Graft Versus Host Disease
Brief Summary This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).
Detailed Description

The study will enroll approximately 84 subjects in two (2) parts:

Part A is an open label study and will enroll approximately 24 evaluable subjects with aGVHD across 4 cohorts. The total number of patients will depend on the number of dose escalations necessary to enable a decision to be made on the recommended dose to take forward into Part B of the study. The planned dose escalation will start with cohort 1, where subjects will receive EQ001 administered intravenously every two weeks for a total of 5 doses.

Part B is a randomized, double-blind, placebo-controlled study and will enroll approximately 60 additional subjects, randomized in a 2:1 ratio to either active treatment EQ001 (40) or placebo (20). Subjects will receive either EQ001 or placebo administered intravenously every two weeks for a total of 5 doses.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Part A is an open label 3+3 dose escalation Part B is blinded and randomized 2:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Part B will be blinded to all study staff that has direct access to the subjects and the sponsor. The site's pharmacist or designee will be unblinded to prepare the study drug.
Primary Purpose: Treatment
Condition  ICMJE
  • Acute-graft-versus-host Disease
  • aGVHD
  • GVHD
  • GVHD, Acute
Intervention  ICMJE
  • Biological: EQ001
    Itolizumab [Bmab 600])
    Other Names:
    • Bmab600
    • Itolizumab
  • Biological: EQ001 Placebo
    EQ001 Placebo
Study Arms  ICMJE
  • Experimental: EQ001 Dose Escalation (Part A)
    Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
    Intervention: Biological: EQ001
  • Experimental: EQ001 (Part B)
    EQ001 administered in a blinded fashion using the optimal dose selected from Part A by intravenous infusion every two weeks for a total of 5 doses.
    Intervention: Biological: EQ001
  • Placebo Comparator: EQ001 Placebo (Part B)
    Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
    Intervention: Biological: EQ001 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2018)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B.
  2. Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens.
  3. Have a clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy.
  4. Deemed by the investigator to be likely to comply with the planned procedure as required by the protocol for the duration of the study

Exclusion Criteria:

  1. Presence of morphologic relapsed primary malignancy, treatment for relapse after alloHSCT was performed, or requirement for rapid immunosuppressive treatment withdrawal for early malignancy relapse.
  2. Evidence of graft failure based on cytopenia(s), and as determined by the investigator.
  3. Evidence of post-transplant lymphoproliferative disease.
  4. Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or systemically administered corticosteroids.
  5. As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect: the subject's participation in this clinical study, the subject's safety, or the reliability of the study data.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vice President, Development Operations 858-412-5302 jrothman@equilliumbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03763318
Other Study ID Numbers  ICMJE EQ001-aGVHD-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Equillium
Study Sponsor  ICMJE Equillium
Collaborators  ICMJE Biocon Limited
Investigators  ICMJE
Study Director: Krishna Polu, MD Equillium
PRS Account Equillium
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP