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 |
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Recruitment Status :
Recruiting
First Posted : December 4, 2018
Last Update Posted : October 8, 2019
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Sponsor:
Equillium
Collaborator:
Biocon Limited
Information provided by (Responsible Party):
Equillium
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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 |
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 : | 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
| Arm | Intervention/treatment |
|---|---|
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Experimental: EQ001 Dose Escalation (Part A)
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
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Biological: EQ001
Itolizumab [Bmab 600])
Other Names:
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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.
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Biological: EQ001
Itolizumab [Bmab 600])
Other Names:
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Placebo Comparator: EQ001 Placebo (Part B)
Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
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Biological: EQ001 Placebo
EQ001 Placebo |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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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:
- Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B.
- Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens.
- Have a clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy.
- 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:
- Presence of morphologic relapsed primary malignancy, treatment for relapse after alloHSCT was performed, or requirement for rapid immunosuppressive treatment withdrawal for early malignancy relapse.
- Evidence of graft failure based on cytopenia(s), and as determined by the investigator.
- Evidence of post-transplant lymphoproliferative disease.
- Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or systemically administered corticosteroids.
- 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.
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
| Contact: Vice President, Development Operations | 858-412-5302 | jrothman@equilliumbio.com |
Locations
| United States, California | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Sandy Tran | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Leighann Montoya | |
| United States, Georgia | |
| Emory University Hospital | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Sharra Triplett | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Nikola Mirkovic | |
| United States, North Carolina | |
| University of North Carolina Lineberger Comprehensive Cancer Center | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Janell Markey | |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Lucy Rolllins | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Lara Edens | |
| United States, Wisconsin | |
| Froedtert & the Medical College of Wisconsin Froedtert Hospital | Recruiting |
| Milwaukee, Wisconsin, United States, 53226-3522 | |
| Contact: Tyler Smith | |
Sponsors and Collaborators
Equillium
Biocon Limited
Investigators
| Study Director: | Krishna Polu, MD | Equillium |
Additional Information:
| Responsible Party: | Equillium |
| ClinicalTrials.gov Identifier: | NCT03763318 History of Changes |
| Other Study ID Numbers: |
EQ001-aGVHD-001 |
| First Posted: | December 4, 2018 Key Record Dates |
| Last Update Posted: | October 8, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |