IMR-687 for Sickle Cell Disease

Not currently recruiting at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Imara, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the long-term safety and tolerability of IMR-687, a new potential drug for people with sickle cell disease. Participants must have completed an earlier study with IMR-687 and be ready to continue with all upcoming assessments and procedures. The trial specifically targets individuals who participated in the previous Phase 2a study, ensuring the treatment remains safe over time. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial staff for guidance.

Is there any evidence suggesting that IMR-687 is likely to be safe for humans?

Research has shown that IMR-687, a treatment under study for sickle cell disease, is generally well-tolerated by patients. One study found that people taking IMR-687 daily experienced few serious side effects, suggesting it is safe for regular use. Another study confirmed its safety, with participants tolerating it well over time. Although the treatment did not meet all its effectiveness goals in one study, it remained safe, with most participants experiencing only mild side effects, if any. These findings are encouraging for those considering joining the trial.12345

Why do researchers think this study treatment might be promising for sickle cell disease?

IMR-687 is unique because, unlike most treatments for sickle cell disease that focus on managing symptoms and complications, it targets the underlying problem at the molecular level. While standard treatments like hydroxyurea work by boosting fetal hemoglobin to reduce sickling, IMR-687 selectively inhibits phosphodiesterase-9 (PDE9), which is thought to increase cyclic guanosine monophosphate (cGMP) levels, potentially leading to improved red blood cell function and reduced sickling. This innovative approach could offer a new way to improve outcomes for patients, making researchers excited about its potential to change the treatment landscape for sickle cell disease.

What evidence suggests that IMR-687 might be an effective treatment for Sickle Cell Disease?

Research has shown that IMR-687, a type of medication, has been tested in both people and animals for sickle cell disease. In mice with sickle cell disease, IMR-687 treatment reduced immune system activity and lowered white blood cell counts, which might be beneficial. Some early human studies also showed positive changes in red and white blood cells, suggesting better blood health. However, a recent large study did not find significant improvements in the main goals measured. While IMR-687 seems safe and well-tolerated, the evidence for its effectiveness in treating sickle cell disease remains mixed. Participants in this trial will receive IMR-687 in an open-label format to further evaluate its potential benefits and safety.13678

Who Is on the Research Team?

KT

Karen Tang, MD

Principal Investigator

Imara, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with Sickle Cell Anemia who finished the IMR-SCD-102 study. Participants must be able to consent, not pregnant or likely to become so, and have normal kidney and liver function tests. They can't join if they have severe anemia or high hemoglobin levels, active hepatitis B/C, malaria events, or HIV.

Inclusion Criteria

I am not pregnant, not breastfeeding, and unlikely to get pregnant.
I am a male and unlikely to father a child.
I understand the study and can sign the consent form.
See 2 more

Exclusion Criteria

eGFR <50 mL/min
AST/ALT > 3x the upper limit of normal
Subjects with Hb >12.5 g/dL or <6 g/dL
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive IMR-687 to evaluate long-term safety and tolerability

49 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IMR-687
Trial Overview The trial is testing the long-term safety and effects of a drug called IMR-687 in adults with Sickle Cell Anemia who previously completed a related Phase 2a study.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Imara, Inc.

Lead Sponsor

Trials
6
Recruited
430+

Citations

A Study of IMR-687 in Subjects With Sickle Cell DiseaseA recently conducted Interim analysis of IMR-SCD-301 demonstrated that while IMR-687 was generally well-tolerated, it failed to meet its primary efficacy ...
A novel, highly potent and selective phosphodiesterase-9 ...Treatment of phosphodiesterase 9A inhibitor (IMR-687) in sickle mice for 30 days results in reduced immune cell activity. White blood cell (WBC) counts are ...
Imara Reports Phase 2a Clinical Trial Results of IMR-687 ...The most frequent adverse events in the IMR-687 treatment arm included sickle cell anemia with crisis, nausea, headache and back pain and were ...
A Study of IMR-687 in Adult Participants With Sickle Cell ...This is a proof-of-concept study in adult SCA participants, ages 18 to 55 years old, to examine the safety, tolerability, ...
s854 imr-687, a highly selective phosphodiesterase 9 ...This interim analysis demonstrates that daily dosing of IMR-687 was safe and well tolerated. Preliminary efficacy data show promising changes in WBC and RBC ...
A Study of IMR-687 in Subjects With Sickle Cell DiseaseA recently conducted Interim analysis of IMR-SCD-301 demonstrated that while IMR-687 was generally well-tolerated, it failed to meet its primary efficacy ...
Benefits and Safety of Long-Term Use of IMR-687 As ...These preliminary results potentially show that extended duration of treatment with IMR-687 could be beneficial to SCD patients as a monotherapy ...
IMR-687, A HIGHLY SELECTIVE PHOSPHODIESTERASE 9 ...IMR-687 is a phosphodiesterase 9 (PDE9) inhibitor in clinical development as a once a day, oral therapy for the treatment of sickle cell disease ...
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