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

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%
Ocular icterus
8%
Pain in extremity
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there similar treatments to IMR-687 that have been trialed before?

"At this moment in time, there is exactly one clinical trial researching IMR-687. Additionally, none of the live studies are in Phase 3 of testing. Most trials for IMR-687 originate from London or Connecticut; however, there are 7 total locations running these tests."

Answered by AI

What are the potential risks associated with taking IMR-687?

"Although there is data suggesting IMR-687 is safe, it only received a 2 because there are no studies proving its efficacy."

Answered by AI

How many people are being studied in this clinical trial at present?

"Unfortunately, this research is not presently enrolling new participants. The trial was originally posted on May 22nd, 2019 and updated as recently as March 2nd, 2022. However, if you are seeking other studies, there are 202 trials actively recruiting patients with anemia and sickle cell disease; in addition, there is 1 study for IMR-687 that is also looking for new patients."

Answered by AI

What are the origins of this trial?

"IMR-687 has been researched since 2019 with the first study being completed that same year. 30 participants were involved in this initial Imara, Inc.-sponsored trial. After Phase 2 clinical approval was received in 2019, there is now a single active trial for IMR-687 again sponsored by Imara, Inc.."

Answered by AI

Is this a full clinical trial or are there still available positions for patients?

"As of right now, this clinical trial is not admitting any more patients. The study was originally posted on May 22nd, 2019 but was edited most recently on March 2nd, 2022. If you're looking for other trials, there are 202 studies for anemia, sickle cell and 1 study for IMR-687 that are still active."

Answered by AI
~5 spots leftby Mar 2025