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EQ001

Phase 1

Acute-graft-versus-host Disease | Monoclonal antibody | Immunology |Equillium, Inc.|Last Updated: Apr 18, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

EQ001 · 2 trials · 5 indications

Phase 1 2
NCT03763318A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHDAcute-graft-versus-host Disease
COMPLETED30 Analytics
NCT04007198A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled AsthmaAsthma
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
Acute-graft-versus-host DiseaseUnlock trial analytics
PHASE1COMPLETED
A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Treatment Emergent Adverse Events
Study Day 85

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

Overall Response Rate
Study Day 29

Overall Response Rate (ORR) is defined as the number of subjects with a partial response (PR), very good partial response (VGPR), or complete response (CR) who are alive at Day 29. Subjects must not have received new systemic therapy for aGVHD before the Day 29 Visit.

Secondary Endpoints

Time to Maximum EQ001serum Concentration, Tmax
Day 337
Maximum EQ001 Serum Drug Concentration, Cmax
Study Day 337
Minimum EQ001 Serum Drug Concentration, Cmin
Study Day 337
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EQ001 Dose Escalation (Part A)EXPERIMENTALOpen label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
EQ001 (Part B)EXPERIMENTALEQ001 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.
EQ001 Placebo (Part B)PLACEBO_COMPARATORPlacebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
EQ001EXPERIMENTALEQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.
EQ001 PlaceboPLACEBO_COMPARATORPlacebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.

Interventions

NameTypeDescription
EQ001BIOLOGICALItolizumab \[Bmab 600\])
EQ001 PlaceboBIOLOGICALEQ001 Placebo
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

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 ...

Countries:United StatesAustraliaNew Zealand
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Frequently asked questions about EQ001

What is EQ001 used for?

EQ001 is an investigational monoclonal antibody being developed for acute graft-versus-host disease (aGVHD) and asthma. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does EQ001 target?

EQ001 targets CD6, a protein involved in T-cell activation and proliferation. By binding to CD6, EQ001 aims to modulate the immune response, which is relevant in conditions like aGVHD and asthma.

Who makes EQ001?

EQ001 is being developed by Equillium, Inc., a biopharmaceutical company. Equillium is publicly traded under the ticker symbol EQ.

What phase is EQ001 in?

EQ001 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in acute graft-versus-host disease and one in asthma, but the drug remains investigational and is not yet approved.

What clinical trials is EQ001 in?

EQ001 has completed two Phase 1 trials. NCT03763318 evaluated EQ001 in subjects with acute graft-versus-host disease, and NCT04007198 studied itolizumab (EQ001) in uncontrolled asthma. Both trials are completed.

Is EQ001 the same as itolizumab?

Yes, EQ001 is also known as itolizumab. In clinical trials, it has been referred to by both names, with NCT04007198 specifically studying itolizumab (EQ001) in asthma.