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Phosphodiesterase 9 (PDE9) Inhibitor

IMR-687 for Sickle Cell Disease

Phase 2
Waitlist Available
Research Sponsored by Imara, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male subjects must be unlikely to impregnate a partner
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 49
Awards & highlights

Study Summary

This trial will evaluate the long-term safety and tolerability of IMR-687 in adult patients who have completed a previous study on the same drug.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, this extension study aims to monitor how safe and tolerable the drug IMR-687 is over a longer period after initial trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a male and unlikely to father a child.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 49
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 49 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with adverse events and serious adverse events
Proportion of patients with changes in clinical laboratory tests
Proportion of patients with changes in safety cardiac parameters
+1 more

Side effects data

From 2020 Phase 2 trial • 100 Patients • NCT03401112
42%
Sickle cell anaemia with crisis
25%
Upper respiratory tract infection
17%
Headache
17%
Influenza like illness
17%
Pain
17%
Nasopharyngitis
17%
Nausea
13%
Uterine leiomyoma
8%
Pain in extremity
8%
Ocular icterus
8%
Hepatic lesion
8%
Abdominal pain upper
8%
Vomiting
8%
Musculoskeletal pain
8%
Diarrhoea
8%
Fatigue
8%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Placebo
Placebo (With HU)
IMR-687 50 mg/100 mg (Without HU)
IMR-687 50 mg/100 mg (With HU)
All IMR-687
IMR-687 100 mg/200 mg (Without HU)
Placebo (Without HU)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMR-687
2018
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Imara, Inc.Lead Sponsor
5 Previous Clinical Trials
403 Total Patients Enrolled
Eleanor Lisbon, MD, MPHStudy DirectorImara, Inc.
5 Previous Clinical Trials
728 Total Patients Enrolled
Karen Tang, MDStudy DirectorImara, Inc.

Media Library

IMR-687 (Phosphodiesterase 9 (PDE9) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04053803 — Phase 2
Sickle Cell Disease Research Study Groups: Open Label
IMR-687 (Phosphodiesterase 9 (PDE9) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04053803 — Phase 2
~4 spots leftby Mar 2025
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