Trial Outcomes & Findings for Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta (NCT NCT05312697)
NCT ID: NCT05312697
Last Updated: 2025-07-23
Results Overview
TERMINATED
PHASE2
2 participants
Retreatment Baseline, Month 12
2025-07-23
Participant Flow
This study recruited adults with osteogenesis imperfecta (OI) who previously participated in the phase 2b, double-blind, dose-finding MBPS205 (ASTEROID) study (NCT03118570).
A total of 2 participants were screened and enrolled. Both participants completed the Baseline visit as part of the Observation Period, and then were discontinued from the study prior to entering the retreatment period as the trial was terminated by the Sponsor.
Participant milestones
| Measure |
Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M
Following an Observation Period, participants enter a Retreatment Period and receive setrusumab administered via intravenous (IV) infusion once a month (QM) for 12 months. During the planned Extension Period, participants are randomized 1:1 to either continue treatment with open-label setrusumab QM or transition to open-label setrusumab every 2 months (Q2M) for at least 12 months or until setrusumab becomes commercially available.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M
Following an Observation Period, participants enter a Retreatment Period and receive setrusumab administered via intravenous (IV) infusion once a month (QM) for 12 months. During the planned Extension Period, participants are randomized 1:1 to either continue treatment with open-label setrusumab QM or transition to open-label setrusumab every 2 months (Q2M) for at least 12 months or until setrusumab becomes commercially available.
|
|---|---|
|
Overall Study
Sponsor Terminated Trial
|
2
|
Baseline Characteristics
Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta
Baseline characteristics by cohort
| Measure |
Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M
n=2 Participants
Following an Observation Period, participants enter a Retreatment Period and receive setrusumab administered via intravenous (IV) infusion once a month (QM) for 12 months. During the planned Extension Period, participants are randomized 1:1 to either continue treatment with open-label setrusumab QM or transition to open-label setrusumab every 2 months (Q2M) for at least 12 months or until setrusumab becomes commercially available.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Retreatment Baseline, Month 12Population: No statistical analyses were performed. No primary analysis occurred, as it was planned to occur at the end of the Retreatment Period, reflecting 12 months of retreatment with setrusumab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Retreatment Baseline, Month 12Population: No statistical analyses were performed. No primary analysis occurred, as it was planned to occur at the end of the Retreatment Period, reflecting 12 months of retreatment with setrusumab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Month 12Population: No statistical analyses were performed. No primary analysis occurred, as it was planned to occur at the end of the Retreatment Period, reflecting 12 months of retreatment with setrusumab.
Outcome measures
Outcome data not reported
Adverse Events
Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER