Trial Outcomes & Findings for Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of ALXN1820 in Adult Participants With Sickle Cell Disease (NCT NCT05565092)
NCT ID: NCT05565092
Last Updated: 2025-01-13
Results Overview
TERMINATED
PHASE2
2 participants
Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)
2025-01-13
Participant Flow
Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Participant milestones
| Measure |
ALXN1820 300 mg QW
Participants received 300 milligrams (mg) once weekly (QW).
|
ALXN1820 600 mg Q4W
Participants received 600 mg once every 4 weeks (Q4W).
|
ALXN1820 300 mg Q2W (Optional Cohort)
Participants received 300 mg once every 2 weeks (Q2W).
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of ALXN1820 in Adult Participants With Sickle Cell Disease
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)Population: Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)Population: Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)Population: Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)Population: Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)Population: Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.
Outcome measures
Outcome data not reported
Adverse Events
ALXN1820 300 mg QW
ALXN1820 600 mg Q4W
ALXN1820 300 mg Q2W (Optional Cohort)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place