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Monoclonal Antibodies

Setrusumab for Osteogenesis Imperfecta (Orbit Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Ultragenyx Pharmaceutical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of OI Types I, III, or IV as confirmed by identification of genetic mutation in collagen, type I, alpha 1 (COL1A1) or collagen, type I, alpha 2 (COLA2)
≥ 1 fracture in the past 12 months, ≥ 2 fractures in the past 24 months or ≥ 1 tibia, femur or humerus fracture in the past 24 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 24
Awards & highlights

Orbit Trial Summary

This trial is testing a new drug, setrusumab, to see if it can reduce the rate of fractures in people with osteogenesis imperfecta (OI), a condition that causes weak bones.

Who is the study for?
This trial is for people with Osteogenesis Imperfecta (OI) Types I, III, or IV who've had fractures in the past year. They must not be on bisphosphonate therapy and agree to use effective contraception. Excluded are those with certain skeletal conditions, unstable neurologic diseases, severe kidney issues, recent drug abuse, hypersensitivity to setrusumab or its components.Check my eligibility
What is being tested?
The study tests Setrusumab against a placebo to find the best dose and see if it lowers fracture rates in OI patients. Participants will either receive Setrusumab or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects of Setrusumab aren't listed here, common ones may include reactions at the injection site, general discomforts like headaches or nausea, potential allergic reactions and possibly effects on bone metabolism.

Orbit Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Osteogenesis Imperfecta Type I, III, or IV confirmed by a genetic test.
Select...
I have had one or more bone fractures in the last year, or two or more in the last two years, including major bones.
Select...
I agree not to take bisphosphonate therapy during the study.
Select...
I am 18 or older and can give my consent, or if under 18, my guardian can consent for me.
Select...
My vitamin D level is at least 20 ng/mL, or I've been supplementing if it was low.
Select...
I agree to use effective birth control during and up to 60 days after the study.

Orbit Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2: Percent Change in Serum Amino-terminal Propeptide of Type 1 Procollagen (P1NP) from Baseline at Month 1
Phase 3: Annualized Rate of all Radiographically-Confirmed Fractures, Excluding Morphometric Vertebral Fractures and Fractures of the Fingers, Toes, Face, and Skull During the Double-Blind Treatment Period
Secondary outcome measures
Phase 2: Baseline-Corrected Area Under the Effect Curve (AUEC) for Serum P1NP Over a 1 and 2-Month Period
Bone and Bones
Phase 2: Number of Participants With Anti-Setrusumab Binding and Neutralizing Antibodies
+14 more

Orbit Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Setrusumab Selected Dose -> OL Setrusumab Selected DoseExperimental Treatment1 Intervention
Double-blind setrusumab selected dose during phase 3 followed by open-label setrusumab During treatment and treatment extension periods, participants may receive supplementation with calcium and vitamin D to maintain normal values as directed by the treating physician
Group II: Low Dose Setrusumab -> Open-Label (OL) Setrusumab Selected DoseExperimental Treatment1 Intervention
Single-blind setrusumab low dose during phase 2 followed by open-label setrusumab selected dose During treatment and treatment extension periods, participants may receive supplementation with calcium and vitamin D to maintain normal values as directed by the treating physician
Group III: High Dose Setrusumab -> OL Setrusumab Selected DoseExperimental Treatment1 Intervention
Single-blind setrusumab high dose during phase 2 followed by open-label setrusumab During treatment and treatment extension periods, participants may receive supplementation with calcium and vitamin D to maintain normal values as directed by the treating physician
Group IV: Placebo -> OL Setrusumab Selected DosePlacebo Group2 Interventions
Double-blind placebo during phase 3 followed by open-label setrusumab During treatment and treatment extension periods, participants may receive supplementation with calcium and vitamin D to maintain normal values as directed by the treating physician

Find a Location

Who is running the clinical trial?

Ultragenyx Pharmaceutical IncLead Sponsor
88 Previous Clinical Trials
178,849 Total Patients Enrolled
5 Trials studying Osteogenesis Imperfecta
190 Patients Enrolled for Osteogenesis Imperfecta
Mereo BioPharmaIndustry Sponsor
22 Previous Clinical Trials
1,503 Total Patients Enrolled
3 Trials studying Osteogenesis Imperfecta
114 Patients Enrolled for Osteogenesis Imperfecta
Ultragenyx Medical DirectorStudy DirectorUltragenyx Pharmaceutical Inc
2 Previous Clinical Trials
796 Total Patients Enrolled

Media Library

Setrusumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05125809 — Phase 2 & 3
Osteogenesis Imperfecta Research Study Groups: Placebo -> OL Setrusumab Selected Dose, Setrusumab Selected Dose -> OL Setrusumab Selected Dose, Low Dose Setrusumab -> Open-Label (OL) Setrusumab Selected Dose, High Dose Setrusumab -> OL Setrusumab Selected Dose
Osteogenesis Imperfecta Clinical Trial 2023: Setrusumab Highlights & Side Effects. Trial Name: NCT05125809 — Phase 2 & 3
Setrusumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05125809 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become a subject in this clinical trial?

"Eligibility for this study requires that patients have been diagnosed with lobstein's disease and are currently between the ages of 5 and 25. A total of 219 patients will be accepted."

Answered by AI

In how many hospitals is this trial currently taking place?

"Presently, this study is being conducted at 29 sites which are situated in Seattle, Calgary, Tampa and 26 other cities. To limit travel commitments, patients should select the clinical trial site nearest to them."

Answered by AI

Has this study been done before?

"Setrusumab is being used in an ongoing clinical trial that began in the year 2022. So far, the drug has been trialled across 23 cities and 12 countries. The original trial, which was sponsored by Mereo BioPharma, had 219 patients enrolled and completed both Phase 2 & 3 of testing. In the years since then, 18292 similar trials have been completed."

Answered by AI

Does Setrusumab have a long history of research?

"At this time, there is 1 active clinical trial studying Setrusumab. Phase 3 trials are still ongoing and 59 different medical centres across Bologna and Tennessee are participating in the research."

Answered by AI

How many individuals are experiencing this medication's effects in a controlled setting?

"That is correct. The information available on clinicaltrials.gov verifies that this trial is still looking for patients to enroll. This research was first made public on February 21st, 2022 and has since been updated October 31st, 2022. There are a total of 29 sites where the study is being conducted and they are hoping to find 219 individuals in total to participate."

Answered by AI

Does this clinical research project have an age limit for participants?

"In order to meet the requirements for this particular clinical trial, applicants must be between 5 and 25 years old. There are 8 similar studies that welcome patients under 18 and 5 more trials open to those over 65."

Answered by AI

Are new participants being enrolled in this trial right now?

"The clinical trial is still recruiting patients, according to the most recent update on clinicaltrials.gov. The study was first posted on February 21st, 2022 and last updated October 31st, 2022."

Answered by AI
~67 spots leftby Mar 2025