TerminatedNCT04411082Updated May 15, 2025Results posted

A Study of IMR-687 in Subjects With Beta Thalassemia

A Phase 2 interventional study of IMR-687 and Placebo in β Thalassemia, sponsored by Cardurion Pharmaceuticals, Inc.. Terminated at 36 sites in 13 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Cardurion Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated

IMR-BTL-201demonstrated that while IMR-687 was generally well-tolerated, it failed to show any meaningful benefit in transfusion burden or improvement in most disease-related biomarkers. So, the sponsor has decided to discontinue this study

Phase: Phase 2
Study type: Interventional
Enrollment: 122
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

A Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia

Read the detailed description

A phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of IMR-687 (phosphodiesterase (PDE) 9 inhibitor) administered once daily (qd) orally for 36 weeks in 2 populations of adult subjects with β-thalassemia: Population 1 (Transfusion Dependent Thalassemia (TDT) subjects) and Population 2 (Non-Transfusion Dependent Thalassemia (NTDT) subjects).

Conditions studied

β Thalassemia

Browse trials for

Thalassemia 250

Keywords

Transfusion
TDT
NTDT

In context

Thalassemia

250 studies on the registry are indexed under Thalassemia; 43 are open to participants now.

This study's enrollment of 122 is above the median of 33 across 170 interventional studies indexed under Thalassemia.

Browse Thalassemia studies →

Lead sponsor

Cardurion Pharmaceuticals, Inc. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Documented diagnosis of β-thalassemia or HbE/ β-thalassemia in their medical history. Concomitant alpha gene deletion, duplication, or triplication is allowed.
Documentation of the dates of transfusion events and the number of all pRBC units per event within the 12 weeks prior to the Baseline (Day 1) visit. .
Must be willing and able to complete all study assessments and procedures, and to communicate effectively with the investigator and site staff.
TDT Subjects: subjects must be regularly transfused, defined as >3 to 10 pRBC units in the12 weeks prior to Baseline (Day 1) visit and no transfusion-free period for >35 days during that period.
NTDT subjects: Subjects must be transfusion independent, defined as 0 to ≤3 units of pRBCs received during the 12-week period prior to the Baseline (Day 1) visit, must not be on a regular transfusion program, must be RBC transfusion-free for at least ≥ 4 weeks prior to randomization, and must not be scheduled to start a regular
hematopoietic stem cell transplantation within 9 months.
NTDT subjects: Subjects must have ≤10.0 g/dL at Screening; the screening Hb sample must be collected 7 to 28 days prior to randomization. Hb values within 21 days post-transfusion will be excluded.
performance score of 0 to 1
Female subjects must not be pregnant, or breastfeeding and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.

Exclusion criteria

Exclusion Criteria:

Diagnosis of α-thalassemia (e.g., H [HbH]) or hemoglobin S (HbS)/ β thalassemia.
(BMI) \<17.0 kg/m2 or a total body weight \<45 kg; or BMI >35 kg/m2
Subjects with known active hepatitis A, , or , with active or acute event of malaria, or who are known to be positive for (HIV).
Stroke requiring medical intervention ≤24 weeks prior to randomization.
count >1000 × 109/L.
Participated in another clinical study of an agent (or device) within 30 days or 5-half-lives of date of , whichever is longer, or is currently participating in another study.
For Subjects on iron chelation therapy (ICT) at the time of ICF signing, initiation of ICT less than 24 weeks before the predicted randomization date.
Prior exposure to sotatercept or luspatercept, IMR-687, or gene therapy within 6 months prior to randomization (Day 1).
Subjects who have major organ damage

Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0: Fully active, no restrictions.
1: Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2: Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3: Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4: Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 122 participants (actual)

Study arms

Experimental
Lower Dose IMR-687
Oral administration of once daily IMR-687
Drug: IMR-687
Experimental
Higher dose IMR-687
Oral administration of once daily IMR-687
Drug: IMR-687
Placebo comparator
Placebo
Oral administration of once daily placebo
Drug: Placebo

Interventions

DrugIMR-687
Oral administration of once daily IMR-687
DrugPlacebo
Oral administration of once daily Placebo

What researchers measure

Primary outcomes

IMR-687 Safety and Tolerability
Incidence and severity of Adverse Events Incidence and severity of Serious Adverse Events
Time frame: Baseline to Week 40

Secondary outcomes

TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 12 to Week 24
Proportion of patients with ≥33% hematological improvement (as measured by reduced transfusion burden) from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1)
Time frame: Baseline to Week 24
NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 12 to Week 24 in the Absence of Transfusions.
Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 12 to Week 24 in the absence of transfusions.
Time frame: Baseline to Week 24
NTDT Patients: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 12 to Week 24 in Absence of Transfusions
Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 12 to Week 24 in absence of transfusions
Time frame: Baseline to Week 24
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 24 to Week 36
Proportion of patients with ≥33% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1)
Time frame: Baseline to Week 36
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50 % Hematological Improvement From Week 12 to Week 24
Proportion of patients with ≥50% hematological improvement from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1)
Time frame: Baseline to Week 24
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50% Hematological Improvement From Week 24 to Week 36
Proportion of patients with ≥50% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1)
Time frame: Baseline to Week 36
NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 24 to Week 36 in the Absence of Transfusions
Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 24 to Week 36 in the absence of transfusions.
Time frame: Baseline to Week 36
NTDT: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 24 to Week 36 in Absence of Transfusions
Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 24 to Week 36 in absence of transfusions
Time frame: Baseline to Week 36

Results

Posted Jun 30, 2022

Participant flow

Participant flow — Overall Study
Milestone	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo
Started	29	25	20	24	12	12
Completed	18	16	16	10	8	6
Not completed	11	9	4	14	4	6

Outcome measures

PrimaryIMR-687 Safety and Tolerability

Incidence and severity of Adverse Events Incidence and severity of Serious Adverse Events

Time frame:: Baseline to Week 40
Reported as:: Count of participants · Participants

IMR-687 Safety and Tolerability
Participants	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo
Treatment emergent Adverse Events	25	22	15	18	12	6
Treatment emergent Adverse Event related to study drug	19	15	8	11	7	4
Grade 3 or greater treatment emergent Adverse Event	4	9	2	4	1	1

SecondaryTDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 12 to Week 24

Proportion of patients with ≥33% hematological improvement (as measured by reduced transfusion burden) from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1)

Time frame:: Baseline to Week 24
Reported as:: Count of participants · Participants

TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 12 to Week 24
Participants	TDT High Dose	TDT Low Dose	TDT Placebo
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 12 to Week 24	2	1	2

Statistical analysis

TDT High Dose vs TDT Low Dose vs TDT Placebo · Fisher Exact · p = >0.99

SecondaryNTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 12 to Week 24 in the Absence of Transfusions.

Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 12 to Week 24 in the absence of transfusions.

Time frame:: Baseline to Week 24
Reported as:: Count of participants · Participants

NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 12 to Week 24 in the Absence of Transfusions.
Participants	NTDT High Dose	NTDT Low Dose	NTDT Placebo
NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 12 to Week 24 in the Absence of Transfusions.	0	0	0

Statistical analysis

NTDT High Dose vs NTDT Low Dose vs NTDT Placebo · Fisher Exact · p = >0.99

SecondaryNTDT Patients: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 12 to Week 24 in Absence of Transfusions

Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 12 to Week 24 in absence of transfusions

Time frame:: Baseline to Week 24
Reported as:: Count of participants · Participants

NTDT Patients: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 12 to Week 24 in Absence of Transfusions
Participants	NTDT High Dose	NTDT Low Dose	NTDT Placebo
NTDT Patients: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 12 to Week 24 in Absence of Transfusions	1	1	0

Statistical analysis

NTDT High Dose vs NTDT Low Dose vs NTDT Placebo · Fisher Exact · p = >0.99

SecondaryTDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 24 to Week 36

Proportion of patients with ≥33% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1)

Time frame:: Baseline to Week 36
Reported as:: Count of participants · Participants

TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 24 to Week 36
Participants	TDT High Dose	TDT Low Dose	TDT Placebo
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 24 to Week 36	0	1	1

Statistical analysis

TDT High Dose vs TDT Low Dose vs TDT Placebo · Fisher Exact · p = >0.4839

SecondaryTDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50 % Hematological Improvement From Week 12 to Week 24

Proportion of patients with ≥50% hematological improvement from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1)

Time frame:: Baseline to Week 24
Reported as:: Count of participants · Participants

TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50 % Hematological Improvement From Week 12 to Week 24
Participants	TDT High Dose	TDT Low Dose	TDT Placebo
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50 % Hematological Improvement From Week 12 to Week 24	0	0	2

Statistical analysis

TDT High Dose vs TDT Low Dose vs TDT Placebo · Fisher Exact · p = 0.2065

SecondaryTDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50% Hematological Improvement From Week 24 to Week 36

Proportion of patients with ≥50% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1)

Time frame:: Baseline to Week 36
Reported as:: Count of participants · Participants

TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50% Hematological Improvement From Week 24 to Week 36
Participants	TDT High Dose	TDT Low Dose	TDT Placebo
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50% Hematological Improvement From Week 24 to Week 36	0	1	1

Statistical analysis

TDT High Dose vs TDT Low Dose vs TDT Placebo · Fisher Exact · p = 0.4839

SecondaryNTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 24 to Week 36 in the Absence of Transfusions

Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 24 to Week 36 in the absence of transfusions.

Time frame:: Baseline to Week 36
Reported as:: Count of participants · Participants

NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 24 to Week 36 in the Absence of Transfusions
Participants	NTDT High Dose	NTDT Low Dose	NTDT Placebo
NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 24 to Week 36 in the Absence of Transfusions	1	1	0

Statistical analysis

NTDT High Dose vs NTDT Low Dose vs NTDT Placebo · Fisher Exact · p = >0.99

SecondaryNTDT: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 24 to Week 36 in Absence of Transfusions

Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 24 to Week 36 in absence of transfusions

Time frame:: Baseline to Week 36
Reported as:: Count of participants · Participants

NTDT: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 24 to Week 36 in Absence of Transfusions
Participants	NTDT High Dose	NTDT Low Dose	NTDT Placebo
NTDT: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 24 to Week 36 in Absence of Transfusions	1	0	0

Statistical analysis

NTDT High Dose vs NTDT Low Dose vs NTDT Placebo · Fisher Exact · p = >0.99

Adverse events

Collected over 10 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
TDT High Dose	0/29 (0%)	1/29 (3.4%)	25/29 (86.2%)
TDT Low Dose	0/25 (0%)	3/25 (12%)	22/25 (88%)
TDT Placebo	0/20 (0%)	1/20 (5%)	15/20 (75%)
NTDT High Dose	0/24 (0%)	3/24 (12.5%)	18/24 (75%)
NTDT Low Dose	0/12 (0%)	0/12 (0%)	12/12 (100%)
NTDT Placebo	0/12 (0%)	0/12 (0%)	6/12 (50%)

Most frequent serious events

Most frequent serious events
Event	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo
COVID19Infections and infestations	0/29	2/25	0/20	0/24	0/12	0/12
Carbon Monoxide PoisoningInjury, poisoning and procedural complications	0/29	0/25	1/20	0/24	0/12	0/12
Lower Respiratory Tract InfectionInfections and infestations	0/29	0/25	0/20	1/24	0/12	0/12
Lower Limb FractureInjury, poisoning and procedural complications	0/29	0/25	0/20	1/24	0/12	0/12
CholelithiasisHepatobiliary disorders	0/29	0/25	0/20	1/24	0/12	0/12
Liver abscessInfections and infestations	0/29	1/25	0/20	0/24	0/12	0/12
PneumoniaInfections and infestations	0/29	1/25	0/20	0/24	0/12	0/12
Back PainMusculoskeletal and connective tissue disorders	1/29	0/25	0/20	0/24	0/12	0/12
RashSkin and subcutaneous tissue disorders	1/29	0/25	0/20	0/24	0/12	0/12
Transfusion ReactionInjury, poisoning and procedural complications	1/29	0/25	0/20	0/24	0/12	0/12

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo
HeadacheNervous system disorders	10/29	10/25	7/20	5/24	2/12	2/12
NauseaGastrointestinal disorders	11/29	6/25	1/20	5/24	1/12	1/12
Abdominal Pain UpperGastrointestinal disorders	2/29	1/25	1/20	3/24	3/12	0/12
DizzinessNervous system disorders	5/29	5/25	2/20	1/24	0/12	1/12
DiarrhoeaGastrointestinal disorders	4/29	1/25	2/20	1/24	2/12	0/12
FatigueGeneral disorders	1/29	0/25	0/20	3/24	2/12	0/12
VomittingGastrointestinal disorders	1/29	0/25	0/20	3/24	2/12	0/12
AnemiaBlood and lymphatic system disorders	0/29	1/25	1/20	2/24	2/12	1/12
COVID19Infections and infestations	1/29	3/25	0/20	3/24	0/12	2/12
GastroenteritisInfections and infestations	3/29	0/25	0/20	0/24	0/12	0/12

Baseline characteristics

Safety Analysis Set

Age, Continuous
Age, Continuous(Years)	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo	Total
Mean	31.7 ± 12.06	30.0 ± 9.95	31.3 ± 8.57	34.1 ± 12.64	28.5 ± 8.21	36.0 ± 9.56	31.9 ± 10.69

Sex: Female, Male
Sex: Female, Male(Participants)	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo	Total
Female	15	15	9	10	6	8	63
Male	14	10	11	14	6	4	59

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo	Total
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	5	7	4	4	3	4	27
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	1	0	0	0	1	0	2
White	19	17	14	17	7	6	80
More than one race	0	0	0	0	0	0	0
Unknown or Not Reported	4	1	2	3	1	2	13

Region of Enrollment
Region of Enrollment(Participants)	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo	Total
United Kingdom	1	0	0	2	0	1	4
Malaysia	4	6	4	3	3	2	22
Greece	9	2	1	5	0	2	19
Lebanon	0	4	3	0	1	0	8
Netherlands	0	0	0	2	0	1	3
Turkey	3	5	7	1	0	0	16
Morocco	1	1	0	2	0	2	6
Denmark	3	0	2	0	0	0	5
Italy	0	0	0	0	1	1	2
Georgia	0	2	1	3	1	1	8
Israel	2	2	2	1	0	0	7
France	2	1	0	0	2	2	7
Tunisia	4	2	0	5	4	0	15

BMI
BMI(kg/m2)	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo	Total
Mean	22.900 ± 3.2252	21.252 ± 2.2874	22.699 ± 2.9968	22.031 ± 3.5415	21.1320 ± 3.5047	21.9120 ± 3.5638	22.0873 ± 3.1573

Serum Ferritin
Serum Ferritin(micrograms per liter)	TDT High Dose	TDT Low Dose	TDT Placebo	NTDT High Dose	NTDT Low Dose	NTDT Placebo	Total
Mean	1724.4 ± 1857.66	3449.1 ± 5093.24	1793.3 ± 1844.72	981.4 ± 951.29	945.8 ± 962.09	447.8 ± 222.32	1726.69 ± 2740.18

Study locations

36 sites

Herlev Hospital
Herlev, Hovedstaden 2730, Denmark
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse cedex 9, Haute-Garonn 31059, France
Hôpital Edouard Herriot
Lyon Cedex 03, Rhone 69437, France
Hôpital Necker-Enfants Malades
Paris, 75015, France
M. Zodelava Hematology Centre
Tbilisi, Borjomi 0112, Georgia
National Center of Surgery
Tbilisi, 0159, Georgia
Medinvest - Institute of Hematology and Transfusiology
Tbilisi, 0186, Georgia
Aghia Sofia General Children's Hospital
Athens, Attica 11527, Greece
Laiko General Hospital of Athens
Athens, Attica 11527, Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloníki, Central Macedonia 54642, Greece
University General Hospital of Patras
Patra, Peloponnese 26504, Greece
Rambam Health Care Campus
Haifa, Haifa District 3109601, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, Jerusalem District 9112001, Israel
The Galilee Medical Center
Nahariya, Northern District 2210001, Israel
Emek Medical Center
Afula, 18101, Israel
Azienda Ospedaliera Giuseppe Brotzu
Orbassano, Turin 10043, Italy
Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
Orbassano, Turin 10043, Italy
Chronic Care Center
Hazmiyeh, 213, Lebanon
Hospital Sultanah Aminah Johor Bharu
Johor Bahru, Johor 80100, Malaysia
Hospital Sultanah Bahiyah
Alor Setar, Kedah 05460, Malaysia
Hospital Pulau Pinang
George Town, Penang 10450, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak 30450, Malaysia
Hospital Queen Elizabeth - Kota Kinabalu
Kota Kinabalu, Sabah 88586, Malaysia
Hospital Umum Sarawak
Kuching, Sarawak 93586, Malaysia
Hôpital d'Enfants Rabat
Rabat, 10100, Morocco
Amsterdam Universitair Medische Centra - Academisch Medisch Centrum
Amsterdam, North Holland 1105 AZ, Netherlands
Centre Hôpital Universitaire Farhat Hached
Sousse, 4000, Tunisia
Centre National de Greffe de la Moelle Osseuse
Tunis, 1006, Tunisia
Hospital Aziza Othmana
Tunis, 1008, Tunisia
Akdeniz Üniversitesi
Mersin, Icel 33110, Turkey
Mersin Üniversitesi Tıp Fakültesi
Mersin, Icel 33110, Turkey
Hacettepe Üniversitesi
Ankara, 06230, Turkey
Ege Universitesi Tip Fakultesi
Izmir, 35100, Turkey
Whittington Health NHS Trust
London, England N19 5NF, United Kingdom
University College London Hospitals NHS Foundation Trust
London, England NW1 2PG, United Kingdom
Manchester University NHS Foundation Trust
Manchester, England M13 9WL, United Kingdom

References and documents

Study documents

Study protocol ↗ · Mar 15, 2021
Statistical analysis plan ↗ · Oct 14, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2020 to primary completion in Mar 2022, 16 months.

Results were first posted in Jun 2022, 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 15, 2020
First posted: Jun 2, 2020
StartActual: Oct 16, 2020
Primary completionActual: Mar 11, 2022
CompletionActual: May 4, 2022
Results first posted: Jun 30, 2022
Last update: May 15, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04411082
Lead sponsor: Cardurion Pharmaceuticals, Inc.
Collaborators: Imara, Inc.
Responsible party: Sponsor
First posted: Jun 2, 2020
Start date: Oct 16, 2020
Primary completion: Mar 11, 2022
Completion: May 4, 2022
Results posted: Jun 30, 2022
Last update: May 15, 2025

Study contacts

Steve Luperchio

study director · Cardurion Pharmaceuticals

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

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This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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A Study of IMR-687 in Subjects With Beta Thalassemia

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