A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects With Sickle Cell Disease

Study point of contact

Amy Gauger
617-206-2020
[email protected]
Jenish Mehta
617-206-2020
[email protected]

Locations

10 United States sites

4 Tunisia sites

3 Lebanon sites

1 Greece site

1 Italy site

1 Netherlands site

1 Oman site

Age

18 to 65 Years

Genotypes

HbSS, HbSB0 thalassemia

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

A Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease

participation requirements

1. Confirmed diagnosis of SCD (HbSS, HbSB0 thalassemia, or HbSB+ thalassemia)

2. Hemoglobin of >5.5 and <10.5 g/dL. 3. Subjects must have had at least 1 and no more than 12 documented episodes of VOCs in the past 12 months at the time of informed consent signing and at randomization (Day 1). 4. Subjects receiving HU must have received it continuously for at least 6 months prior to signing informed consent, and must have been on a stable dose for at least 3 months prior to signing the informed consent, with no anticipated need for dose adjustments during the study including the screening period, in the opinion of the investigator. 5. Female subjects must not be pregnant or breastfeeding and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner. 6. Must be willing and able to complete all study assessments and procedures, and to communicate effectively with the investigator and site staff.

participation restrictions

1. Body mass index (BMI) <17.0 kg/m2 and a total body weight <45 kg; or a BMI >35 kg/m2.

2. Subjects with known active hepatitis A, hepatitis B, or hepatitis C, with active or
acute event of malaria, or who are known to be positive for human immunodeficiency
virus (HIV).

3. Stroke requiring medical intervention within 24 weeks prior to randomization.

4. Prior exposure to IMR-687.

5. A history of use of crizanlizumab or voxelotor within 6 months prior to signing the
informed consent.

6. Receipt of erythropoietin or other hematopoietic growth factor treatment within 3
months of signing the ICF or anticipated need for such agents during the study.

7. Prior gene therapy.

Locations

  • Birmingham, Alabama, United States, University of Alabama at Birmingham School of Medicine - 1917 Clinic, 35233 [Recruiting]
  • Little Rock, Arkansas, United States, Arkansas Primary Care Clinic, 72204 [Recruiting]
  • Santa Ana, California, United States, Center For Inherited Blood Disorders, 92705 [Recruiting]
  • Whittier, California, United States, The Oncology Institute Long Beach, 90603 [Recruiting]
  • Farmington, Connecticut, United States, University of Connecticut Health Main Building, 06030 [Recruiting]
  • Atlanta, Georgia, United States, Children's Healthcare of Atlanta, 30342 [Recruiting]
  • Chicago, Illinois, United States, The University of Illinois at Chicago College of Medicine, 60612-4333 [Recruiting]
  • Baltimore, Maryland, United States, Johns Hopkins Hospital, 21287 [Recruiting]
  • Temple, Texas, United States, Baylor Scott & White Medical Center-Temple, 76508 [Recruiting]
  • Richmond, Virginia, United States, Virginia Commonwealth University Health - Ambulatory Care Center, 23219 [Recruiting]
  • Athens, Attica, Greece, Laiko General Hospital of Athens, 11526 [Recruiting]
  • Roma, Rome, Italy, Fondazione Policlinico Universitario Agostino Gemelli, 00168 [Recruiting]
  • Tripoli, North Governorate, Lebanon, Hopital Nini [Recruiting]
  • Beirut, Lebanon, American University of Beirut Medical Center, 01107 2020 [Recruiting]
  • Hazmiyeh, Lebanon, Chronic Care Center [Recruiting]
  • Den Haag, South Holland, Netherlands, Hagaziekenhuis Van Den Haag - Leyweg, 2545 AA [Recruiting]
  • Muscat, Oman, Sultan Qaboos University Hospital, 123 [Recruiting]
  • Sfax, Tunisia, Hedi Chaker Hospital, 3089 [Recruiting]
  • Sousse, Tunisia, Centre Hôpital Universitaire Farhat Hached, 4000 [Recruiting]
  • Tunis, Tunisia, Centre National de Greffe de la Moelle Osseuse, 1006 [Recruiting]
  • Tunis, Tunisia, Hospital Aziza Othmana, 1008 [Recruiting]
Last updated 2021-02-24 Enroll Now