Immune ThrombocytopeniaPhase 1NCT07605845
Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
A Phase 1 study testing GL-2045 in people with Immune Thrombocytopenia, run by Gliknik Inc. at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- GL-2045
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2026to 6 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.
- Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.
- A platelet count of 10 to 49 × 10^9/L at baseline.
- Study subjects must have prior response to corticosteroids or to intravenous immunoglobin (IVIg) documented by a consultant hematologist. Prior response to thrombopoietin receptor agonists is insufficient for eligibility.
- The subject may be on a stable dose of corticosteroids for the 3 months prior to study entry, limited to a daily dose of prednisone 10 mg or equivalent. No reductions or increases of steroids are allowed during the study.
Who cannot join
- Any serious adverse event (SAE) with prior IVIg dosing.
- Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.
- Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.
- Abnormal organ function including liver and kidney.
- Any previous or current treatments prohibited by the protocol.
- Treatment within the last 4 weeks or intention to treat during the study with a thrombopoietin receptor agonist including romiplostim (Nplate®), eltrombopag (Revolade®), or avatrombopag (Doptelet®).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Fortrea Clinical Research Unit Ltd
Leeds, LS11 9EH
About this study
Official title: Initial Safety and Efficacy, Sequential Group, Adaptive Dose Study of GL-2045 Subcutaneous Injection Repeat Doses in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
Read the detailed description
This is a Phase 1b, open-label, multiple subcutaneous (SC) injection dose study in participants with ITP. The specific aims of this study are to determine:
- The safety of the study drug when given to participants with ITP
- The effect of the study drug on safety blood tests and blood platelet counts
- How the study drug affects certain responses in the body such as severity of bleeding, levels of fatigue and health-related quality of life
- How much of the study drug gets into the bloodstream
- The body's immune response to the study drug
This information, together with pharmacokinetic (PK) data, will help to establish doses and dosing regimens suitable for use in future studies. The effects of GL-2045 on multiple biomarkers will also be investigated.
- Conditions
- Immune Thrombocytopenia
- Being tested
- GL-2045
- Keywords
- Adult ITP
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GL-2045Drug
Administrative route: SC injection
| Study group | Role | What they receive |
|---|---|---|
| GL-2045 | Experimental | Participants will receive GL-2045 by SC injection during the treatment period.
Cohort 1: Adaptive design cohort during which dose adjustment may occur. Up to 18 participants will be enrolled
Cohort 2: Fixed-dose and dosing frequency testing 1 or 2 dose levels and dose regimens. Up to 24 participants will be enrolled Receives: Drug: GL-2045 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and type of adverse events and laboratory abnormalities
Measured: Screening (Days -28 to -2) to Follow-up (Day 55)
Multiple measurements of change from baseline in platelet count
Measured: Day -1 to Follow-up (Day 55)
Secondary outcomes (9)
Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Levels
Measured: Day 1 to Follow-up (Day 55)
Change from Baseline in Classical Complement Pathway (CCP) Inhibition
Measured: Day 1 to Follow-up (Day 55)
Changes in bleeding scale
Measured: Day -1 to Follow-up (Day 55)
Changes from baseline in Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Questionnaire
Measured: Day -1 to Follow-up (Day 55)
Changes from baseline in FACIT-Thrombocytopenia 6 Questionnaire
Measured: Day -1 to Follow-up (Day 55)
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUCO-tlast)
Measured: Day 1 to Follow-up (Day 55)
Maximum observed concentration (Cmax)
Measured: Day 1 to Follow-up (Day 55)
Time of the maximum observed concentration (tmax)
Measured: Day 1 to Follow-up (Day 55)
Incidence of immune response to drug
Measured: Day 1 to Day 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start14 Apr 2026
- Primary completion6 Dec 2027 (estimated)
- Study completion6 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gliknik Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MBChB, PhD, Principal investigator, Fortrea Clinical Research Unit Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605845
- Sponsor's protocol ID
- GL-2045-03
- Other IDs
- 2025-522629-36, 2025
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Safety and Efficacy, Sequential Group, Adaptive Dose Study of GL-2045 Subcutaneous Injection Repeat Doses in Patients With Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07605845
- Acronym / sponsor ID
- GL-2045-03
- Conditions
- Immune Thrombocytopenia
- Keywords
- Adult ITP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Gliknik Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 6 Dec 2027 (estimated)
- Study completion
- 6 Dec 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
Detailed description
This is a Phase 1b, open-label, multiple subcutaneous (SC) injection dose study in participants with ITP. The specific aims of this study are to determine:
- The safety of the study drug when given to participants with ITP
- The effect of the study drug on safety blood tests and blood platelet counts
- How the study drug affects certain responses in the body such as severity of bleeding, levels of fatigue and health-related quality of life
- How much of the study drug gets into the bloodstream
- The body's immune response to the study drug
This information, together with pharmacokinetic (PK) data, will help to establish doses and dosing regimens suitable for use in future studies. The effects of GL-2045 on multiple biomarkers will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GL-2045 | Experimental | Drug: GL-2045Participants will receive GL-2045 by SC injection during the treatment period. Cohort 1: Adaptive design cohort during which dose adjustment may occur. Up to 18 participants will be enrolled Cohort 2: Fixed-dose and dosing frequency testing 1 or 2 dose levels and dose regimens. Up to 24 participants will be enrolled |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.
- Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.
- A platelet count of 10 to 49 × 10^9/L at baseline.
- Study subjects must have prior response to corticosteroids or to intravenous immunoglobin (IVIg) documented by a consultant hematologist. Prior response to thrombopoietin receptor agonists is insufficient for eligibility.
- The subject may be on a stable dose of corticosteroids for the 3 months prior to study entry, limited to a daily dose of prednisone 10 mg or equivalent. No reductions or increases of steroids are allowed during the study.
Key exclusion criteria (6 listed)
- Any serious adverse event (SAE) with prior IVIg dosing.
- Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.
- Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.
- Abnormal organ function including liver and kidney.
- Any previous or current treatments prohibited by the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GL-2045Administrative route: SC injection | Drug | GL-2045 |
Primary outcome
Incidence, severity and type of adverse events and laboratory abnormalities
Time frame: Screening (Days -28 to -2) to Follow-up (Day 55)
Multiple measurements of change from baseline in platelet count
Time frame: Day -1 to Follow-up (Day 55)
9 secondary outcomes
Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Levels
Time frame: Day 1 to Follow-up (Day 55)
Change from Baseline in Classical Complement Pathway (CCP) Inhibition
Time frame: Day 1 to Follow-up (Day 55)
Changes in bleeding scale
Time frame: Day -1 to Follow-up (Day 55)
Changes from baseline in Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Questionnaire
Time frame: Day -1 to Follow-up (Day 55)
Changes from baseline in FACIT-Thrombocytopenia 6 Questionnaire
Time frame: Day -1 to Follow-up (Day 55)
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUCO-tlast)
Time frame: Day 1 to Follow-up (Day 55)
Maximum observed concentration (Cmax)
Time frame: Day 1 to Follow-up (Day 55)
Time of the maximum observed concentration (tmax)
Time frame: Day 1 to Follow-up (Day 55)
Incidence of immune response to drug
Time frame: Day 1 to Day 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jim Bush, MBChB, PhD principal investigator
Fortrea Clinical Research Unit Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GL-2045 in people with Immune Thrombocytopenia, run by Gliknik Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gliknik Clinical Trials Group (410-665-0662, gliknikclinicaltrialinquiries@gliknik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and type of adverse events and laboratory abnormalities (time frame: Screening (Days -28 to -2) to Follow-up (Day 55)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.