Phase 2
N=100
A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT03401112 ↗Enrolled (actual)
100
Serious AEs
29.0%
Results posted
Apr 2022
Primary outcome: Primary: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs) — 12; 24; 18; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IMR-687 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardurion Pharmaceuticals, Inc.
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs) |
12; 24; 18; 23; 10; 59 | — |
| SECONDARY Pharmacokinetic (PK) Of Participants Who Did Not Concomitantly Receive HU: Maximum Plasma Concentration (Cmax) Of IMR-687 |
512; 1130; 1290; 2180 | — |
| SECONDARY PK Of Participants Who Did Not Concomitantly Receive HU: Area Under The Concentration-time Curve (AUC) From Time 0 To 24 Hours Postdose (AUC0-24h) Of IMR-687 |
2850; 6590; 8420; 15000 | — |
| SECONDARY PK Of Participants Who Concomitantly Received HU: Cmax Of IMR-687 |
657; 1370 | — |
| SECONDARY PK Of Participants Who Concomitantly Received HU: AUC0-24h Of IMR-687 |
3090; 7300 | — |
| SECONDARY PK Of Participants Who Concomitantly Received HU: Cmax Of HU |
25.3; 20.6; 24.8; 25.4; 24.5; 20.5 | — |
| SECONDARY PK Of Participants Who Concomitantly Received HU: AUC0-24h Of HU |
99.2; 113; 103; 129; 122; 91.4 | — |
Summary
Study of IMR-687 in adult participants with sickle cell anemia (SCA) (homozygous HbSS or sickle-β0 thalassemia).
Eligibility 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 7 hospitalizations for vaso-occlusive crises (VOCs) within the last year
- Estimated glomerular filtration rate 3x the upper limit of normal
Data sourced from ClinicalTrials.gov (NCT03401112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.