NCT05125809ACTIVE_NOT_RECRUITINGanonymous

An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta

Sponsor

Source record

Ultragenyx Pharmaceutical Inc

Phase

Source record

PHASE2

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Setrusumab, Placebo

Indication / condition

AI-normalized

Osteogenesis Imperfecta

Intervention

Source record

Setrusumab, Placebo

Source & freshness

Source record

NCT ID

NCT05125809

Original source

ClinicalTrials.gov

Source last updated

Feb 25, 2026

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record

View original source fields

NCT ID

NCT05125809

Title

An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta

Sponsor

Ultragenyx Pharmaceutical Inc

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE2

Condition raw

Osteogenesis Imperfecta

Condition normalized

Osteogenesis Imperfecta

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Setrusumab, Placebo

Target normalized

Setrusumab, Placebo

Interventions

Setrusumab, Placebo

Public preview

Source record

The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

Report access

Create an account to unlock this report

Choose the access model that matches the job: one urgent report, reusable credits for project work, or unlimited monthly access with AI and folders.

Full protocol, outcomes, eligibility, contacts and results sections

Patent/IP landscape with verified records when available

Board-ready PDF export with source provenance

Save to folders and synthesize multiple assets in premium workspace

Create account

Create a free account first, then unlock a single report, buy credits or subscribe.

TrialSignal

Clinical trial intelligence report

An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT05125809

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE2

Sponsor

Ultragenyx Pharmaceutical Inc

Executive brief

Investment-Ready Snapshot

The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.

Source & freshness

Provenance

SourceClinicalTrials.gov

Source updatedFeb 25, 2026

Internal syncJun 11, 2026

Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05125809

Indication

Osteogenesis Imperfecta

Modality

monoclonal antibody

Target

Setrusumab, Placebo

Intervention

Setrusumab, Placebo

Source record