Sickle Cell DiseasePhase 2NCT04053803
An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia
A Phase 2 study testing IMR-687 in people with Sickle Cell Disease, run by Imara, Inc. at 7 sites in 2 countries.
Trial summary
This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- IMR-687
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 22 May 2019to Mar 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed Study IMR-SCD-102.
- Female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
- Subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them
- Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.
Who cannot join
- Subjects with Hb >12.5 g/dL or <6 g/dL
- Subjects with known active hepatitis B or hepatitis C, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (HIV)
- eGFR <50 mL/min
- AST/ALT > 3x the upper limit of normal
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United Kingdom4 sites
Bristol Haematology and Oncology Centre
Bristol
University College London Hospital NHS Foundation Trust
London, NW1 2PG
Guy's and St Thomas Hospital CRF
London
Royal London Hospital
London
United States3 sites
University of Connecticut Health Center
Farmington, Connecticut, 06030
Foundation for Sickle Cell Disease Research
Hollywood, Florida, 33021
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
About this study
Official title: An Open-label Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia) Who Participated in Study IMR-SCD-102
This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerability.
Read the detailed description
This is an open-label extension study of IMR-687 in adult patients with SCA who were previously participants in the Phase 2a study titled "A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients with Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)."
This open-label extension study with IMR-687 will evaluate the long-term safety and tolerability of IMR 687 in adult SCA patients. Exploratory long-term PD parameters will also be examined.
- Conditions
- Sickle Cell Disease
- Being tested
- IMR-687
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMR-687Drug
Oral administration of once daily IMR-687
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Not described Receives: Drug: IMR-687 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with adverse events and serious adverse events
- Incidence of Adverse Events
- Incidence of Serious Adverse Events
Measured: Baseline to Month 49
Proportion of patients with changes in safety cardiac parameters
- Changes in 12-lead ECG parameters that are clinically significant and measured in milliseconds (ms).
The parameters are: PR interval, QRS duration, QT interval, ST segment duration and T wave duration.
Measured: Baseline to Month 49
Proportion of patients with changes in clinical laboratory tests
- Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis
Measured: Baseline to Month 49
Proportion of patients with clinically significant abnormal vital signs
- Blood pressure measured in mmHg
- Pulse measured in beats per minute
- Respiration rate measured in breaths per minutes
- Temperature as measured in degrees F0 or C0
Measured: Baseline to Month 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start22 May 2019
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imara, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Tang, MD, Study director, Imara, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053803
- Sponsor's protocol ID
- IMR-SCD-102-EXT
- Other IDs
- 2018-003805-25, 2018
- Status last verified
- Mar 2022
- First submitted
- 18 Jul 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia) Who Participated in Study IMR-SCD-102
- ClinicalTrials.gov ID
- NCT04053803
- Acronym / sponsor ID
- IMR-SCD-102-EXT
- Conditions
- Sickle Cell Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imara, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2019 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 13 Aug 2019 (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.
This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerability.
Detailed description
This is an open-label extension study of IMR-687 in adult patients with SCA who were previously participants in the Phase 2a study titled "A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients with Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)."
This open-label extension study with IMR-687 will evaluate the long-term safety and tolerability of IMR 687 in adult SCA patients. Exploratory long-term PD parameters will also be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: IMR-687 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completed Study IMR-SCD-102.
- Female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
- Subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them
- Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.
Key exclusion criteria (4 listed)
- Subjects with Hb >12.5 g/dL or <6 g/dL
- Subjects with known active hepatitis B or hepatitis C, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (HIV)
- eGFR <50 mL/min
- AST/ALT > 3x the upper limit of normal
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 |
|---|---|---|
| IMR-687Oral administration of once daily IMR-687 | Drug | Open Label |
Primary outcome
Proportion of patients with adverse events and serious adverse events
Time frame: Baseline to Month 49
1. Incidence of Adverse Events 2. Incidence of Serious Adverse Events
Proportion of patients with changes in safety cardiac parameters
Time frame: Baseline to Month 49
a. Changes in 12-lead ECG parameters that are clinically significant and measured in milliseconds (ms). The parameters are: PR interval, QRS duration, QT interval, ST segment duration and T wave duration.
Proportion of patients with changes in clinical laboratory tests
Time frame: Baseline to Month 49
a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis
Proportion of patients with clinically significant abnormal vital signs
Time frame: Baseline to Month 49
1. Blood pressure measured in mmHg 2. Pulse measured in beats per minute 3. Respiration rate measured in breaths per minutes 4. Temperature as measured in degrees F0 or C0
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 4 Mar 2022.
Related trials for Sickle Cell Disease
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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. This study is not recruiting at the moment.
Karen Tang, MD study director
Imara, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMR-687 in people with Sickle Cell Disease, run by Imara, Inc. at 7 sites in 2 countries.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with adverse events and serious adverse events (time frame: Baseline to Month 49). The study lists 4 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 4 Mar 2022.