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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 : June 30, 2020
Sponsor:
Collaborator:
Biocon Limited
Information provided by (Responsible Party):
Equillium

Study Description
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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).

Condition or disease Intervention/treatment Phase
Acute-graft-versus-host Disease aGVHD GVHD GVHD, Acute Biological: EQ001 Biological: EQ001 Placebo Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
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
Official Title: 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
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EQ001 Dose Escalation (Part A)
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
 Biological: EQ001
Itolizumab [Bmab 600])
Other Names:
  • Bmab600
  • Itolizumab
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.
 Biological: EQ001
Itolizumab [Bmab 600])
Other Names:
  • Bmab600
  • Itolizumab
Placebo Comparator: EQ001 Placebo (Part B)
Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
 Biological: EQ001 Placebo
EQ001 Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Time to maximum EQ001serum concentration, Tmax [ Time Frame: Study Day 337 ]
    Time to maximum EQ001 serum concentration, Tmax

  2. Maximum EQ001 serum drug concentration, Cmax [ Time Frame: Study Day 337 ]
    Maximum EQ001 serum drug concentration, Cmax

  3. Minimum EQ001 serum drug concentration, Cmin [ Time Frame: Study Day 337 ]
    Minimum EQ001 serum drug concentration prior to next dose, Cmin

  4. 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)

  5. Half life of EQ001, t1/2 [ Time Frame: Study Day 337 ]
    Half life of EQ001, t1/2

  6. Volume of distribution of EQ001, Vd [ Time Frame: Study Day 337 ]
    Volume of distribution of EQ001, Vd

  7. Clearance, Cl [ Time Frame: Study Day 337 ]
    Clearance, Cl

  8. 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

  9. CD6 receptor occupancy [ Time Frame: Study Day 337 ]
    CD6 receptor occupancy


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763318


Contacts
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Contact: Vice President, Development Operations 858-412-5302 jrothman@equilliumbio.com

Locations
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Sponsors and Collaborators
Equillium
Biocon Limited
Investigators
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Study Director: Krishna Polu, MD Equillium
More Information
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Additional Information:

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Responsible Party: Equillium
ClinicalTrials.gov Identifier: NCT03763318    
Other Study ID Numbers: EQ001-aGVHD-001
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases