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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06291415




Registration number
NCT06291415
Ethics application status
Date submitted
13/02/2024
Date registered
4/03/2024
Date last updated
4/06/2024

Titles & IDs
Public title
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
Scientific title
A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia
Secondary ID [1] 0 0
2022-523-GLOB1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune Thrombocytopenia 0 0
Blood Platelet Disorder 0 0
Hematologic Diseases 0 0
Purpura, Thrombocytopenic 0 0
Purpura 0 0
Blood Coagulation Disorder 0 0
Thrombotic Microangiopathies 0 0
Hemorrhagic Disorders 0 0
Autoimmune Diseases 0 0
Immune System Diseases 0 0
Hemorrhage 0 0
Pathologic Processes 0 0
Skin Manifestations 0 0
Thrombocytopenia 0 0
Purpura, Thrombocytopenic, Idiopathic 0 0
Primary Immune Thrombocytopenia 0 0
ITP - Immune Thrombocytopenia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HMPL-523

Experimental: Dose escalation - Part 1 will consist of the following 3 dose levels: 300, 400, and 500 mg once daily (QD).

Experimental: Dose optimization stage - In part 2 subjects will be randomized in a 1:1 ratio between the 2 dose levels selected at the end of part 1.


Treatment: Drugs: HMPL-523
Syk inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of HMPL-523 in adult subjects with primary ITP
Timepoint [1] 0 0
week 1 - week 24
Primary outcome [2] 0 0
Dose Limiting Toxicities
Timepoint [2] 0 0
week 1 - week 4
Secondary outcome [1] 0 0
Cmax (maximum plasma drug concentration)
Timepoint [1] 0 0
week 1 and week 3
Secondary outcome [2] 0 0
AUCtau (area under the concentration-time curve over a dosage interval)
Timepoint [2] 0 0
week 1 and week 3
Secondary outcome [3] 0 0
Tmax (time to reach maximum plasma drug concentration)
Timepoint [3] 0 0
week 1 and week 3
Secondary outcome [4] 0 0
Cmin (minimum plasma drug concentration)
Timepoint [4] 0 0
week 1 - week 20

Eligibility
Key inclusion criteria
Subjects may be enrolled in this study only if they satisfy all the following criteria:

1. Adult male or female subjects =18 years of age

2. Diagnosis of ITP, with a duration of disease of at least 3 months prior to
randomization or enrollment

3. Intolerance or insufficient response or recurrence after at least 1 prior ITP
treatment (excluding splenectomy)

4. Response (defined as achieved a platelet count =50 × 109/L) to at least 1 prior ITP
therapy (including splenectomy)

5. Adequate hematologic, hepatic and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects are not eligible for enrollment into this study if any one of the following
criteria are met:

1. Evidence of the presence of secondary causes of ITP

2. Clinically serious hemorrhage requiring immediate adjustment of platelets

3. Known history of vital organ transplantation or hematopoietic stem-cell
transplantation or chimeric antigen receptor T-cells (CAR-T) therapy

4. Splenectomy within 12 weeks prior to enrollment

5. Presence of active malignancy unless deemed cured by adequate treatment.

6. History of serious cardiovascular disease corrected QT interval (QTcF) =450 ms

7. Uncontrolled hypertension

8. Being unsuitable to participate in this study as considered by investigators

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [2] 0 0
The Perth Blood Institute (PBI) Hollywood Specialist Centre - West Perth
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Canberra Hospital - Canberra
Recruitment postcode(s) [1] 0 0
- Frankston
Recruitment postcode(s) [2] 0 0
- West Perth
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Canberra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New Mexico
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Düsseldorf
Country [13] 0 0
Germany
State/province [13] 0 0
Göttingen
Country [14] 0 0
Germany
State/province [14] 0 0
Lübeck
Country [15] 0 0
Norway
State/province [15] 0 0
Grålum
Country [16] 0 0
Norway
State/province [16] 0 0
Oslo
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Spain
State/province [18] 0 0
Burgos
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Murcia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hutchmed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy
of HMPL-523 in adult subjects with ITP.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06291415
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vijay Jayaprakash, MD, PhD
Address 0 0
Hutchmed
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nick Lawn
Address 0 0
Country 0 0
Phone 0 0
+1-973-306-4490
Fax 0 0
Email 0 0
2022-523-GLOB1@hutch-med.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06291415