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 : March 13, 2019
|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|
|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.|
|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|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||February 28, 2022|
Experimental: EQ001 Dose Escalation (Part A)
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
Itolizumab [Bmab 600])
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.
Itolizumab [Bmab 600])
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
- 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
- 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
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
|Contact: Vice President, Development Operationsfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Nikola Mirkovic|
|Study Director:||Krishna Polu, MD||Equillium|