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A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)

I

Imara

Status and phase

Completed
Phase 2

Conditions

Sickle Cell Disease

Treatments

Drug: IMR-687
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03401112
IMR-SCD-102
2017-000653-39 (EudraCT Number)

Details and patient eligibility

About

Study of IMR-687 in adult participants with sickle cell anemia (SCA) (homozygous HbSS or sickle-β0 thalassemia).

Full description

This is a proof-of-concept study in adult SCA participants, ages 18 to 55 years old, to examine the safety, tolerability, and pharmacokinetic (PK), as well as the potential pharmacodynamic (PD) effects and clinical efficacy, of IMR-687 across a range of doses.

IMR-687 was administered in 2 populations of participants with SCA: those who were not receiving hydroxyurea (HU) and those who were receiving a stable dose of HU according to standard of care.

Enrollment

100 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Male or female participants with confirmed SCA
  • Age 18 to 55 years, inclusive
  • For participants on HU, must have been on a stable dose for at least 60 days prior to screening

Key Exclusion Criteria:

  • Total hemoglobin >12.5 or <6 grams/deciliter
  • Red blood cell transfusion within 60 days of baseline
  • >7 hospitalizations for vaso-occlusive crises (VOCs) within the last year
  • Estimated glomerular filtration rate <50 milliliter/minute
  • Aspartate aminotransferase/alanine aminotransferase >3x the upper limit of normal

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 3 patient groups, including a placebo group

IMR-687 50 mg/100 mg
Experimental group
Description:
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants. Duration of administration was 16 (Week 17) or 24 weeks (Week 25).
Treatment:
Drug: IMR-687
IMR-687 100 mg/200 mg
Experimental group
Description:
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants. Duration of administration was 24 weeks (Week 25).
Treatment:
Drug: IMR-687
Placebo
Placebo Comparator group
Description:
Matching placebo was administered for 16 (Week 17) or 24 weeks (Week 25).
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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