Trial · NCT05125809
Setrusumab vs Placebo for Osteogenesis Imperfecta
NCT05125809, Phase 2, Phase 3, Active not recruiting, Ultragenyx Pharmaceutical Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Setrusumab vs Placebo for Osteogenesis Imperfecta. Trials, record NCT05125809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05125809
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Setrusumab vs Placebo for Osteogenesis Imperfecta
- NCT number
- NCT05125809
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 183 participants, actual
- Lead sponsor
- Ultragenyx Pharmaceutical Inc
- Conditions
- Osteogenesis Imperfecta
- Interventions
- Setrusumab, Placebo
- First posted
- 2021-11-18
- Last updated
- 2026-10-20
- Other registries' IDs
- eudract:2021-006597-23
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 2: Percent Change in Serum Amino-terminal Propeptide of Type 1 Procollagen (P1NP) from Baseline at Month 1 | Baseline, Month 1 | |
| Primary | Phase 3: Annualized Rate of All Radiographically-Confirmed Fractures, Excluding Morphometric Vertebral Fractures and Fractures of the Fingers, Toes, Face, and Skull at the Primary Analysis | Up to Month 24 | |
| Secondary | Phase 2: Serum Setrusumab Concentration | From Predose up to Month 24 | |
| Secondary | Phase 2: Baseline-Corrected Area Under the Effect Curve (AUEC) for Serum P1NP Over a 1 and 2-Month Period | Baseline, Up to Month 2 | |
| Secondary | Phase 2: Percent Change from Baseline Over Time in Bone Turnover Marker: P1NP | Baseline, Up to Month 24 | |
| Secondary | Phase 2: Percent Change from Baseline Over Time in Bone Turnover Marker: Osteocalcin (OCN) | Baseline, Up to Month 24 | |
| Secondary | Phase 2: Change from Baseline in Dual Energy X-ray (DXA) Lumbar Spine Bone Mineral Density (BMD) Z-score Over Time | Baseline, Up to Month 24 | |
| Secondary | Phase 2: Percent Change from Baseline in DXA Lumbar Spine BMD Over Time | Baseline, Up to Month 24 | |
| Secondary | Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Up to Month 24 | |
| Secondary | Phase 2: Number of Participants With Anti-Setrusumab Binding and Neutralizing Antibodies | Up to Month 24 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42470570 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05125809
GET https://conductscience.org/api/trials/v1/NCT05125809/registered