Trial · NCT06450886
Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis
NCT06450886, Phase 2, Phase 3, Active not recruiting, Abcuro, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis. Trials, record NCT06450886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06450886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis
- NCT number
- NCT06450886
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 270 participants, estimated
- Lead sponsor
- Abcuro, Inc.
- Conditions
- Inclusion Body Myositis (IBM)
- Interventions
- Ulviprubart (ABC008)
- First posted
- 2024-06-10
- Last updated
- 2025-07-28
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Endpoint | From Baseline (Day 1) through study completion, an average of 156 weeks.] | The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs). Safety as assessed by the incidence, type and severity of Treatment Emergent Adverse Events (TEAEs) |
| Secondary | Treatment Emergent Serious Adverse Events (TEASAEs) | From Baseline (Day 1) through study completion, an average of 156 weeks.] | Incidence, type, and severity of treatment-emergent serious adverse events (TESAEs) |
| Secondary | Treatment Emergent Adverse Events (TEAEs) onset within 24 hours of Study Medication Administration. | From Baseline (Day 1) through study completion, an average of 156 weeks.] | Incidence of TEAEs leading to study medication or study discontinuation |
| Secondary | Adverse Events of Special Interest (AESI) | From Baseline (Day 1) through study completion, an average of 156 weeks.] | Incidence of Adverse events of special interest (AESIs) |
| Secondary | Change from baseline standard laboratory parameters (Hematology) | From Baseline (Day 1) through study completion, an average of 156 weeks.] | Incidence of clinically significant changes in standard laboratory parameters (Hematology) |
| Secondary | Change from baseline in standard laboratory parameters (Chemistry) | From Baseline (Day 1) through study completion, an average of 156 weeks.] | Incidence of clinically significant changes from baseline in standard laboratory parameters (Chemistry) |
| Secondary | Change from baseline in standard laboratory parameters (Coagulation) | From Baseline (Day 1) through study completion, an average of 156 weeks.] | Incidence of clinically significant changes from baseline standard laboratory parameters (Coagulation) |
| Secondary | Inclusion Body Myositis Functional Rating Scale (IBMFRS) | From Baseline (Day 1) through study completion, an average of 156 weeks.] | Mean change from Baseline (Day 1) in IBMFRS over the duration of the study |
| Secondary | Manual Muscle Test 12 (MMT 12) | From Baseline (Day 1) through study completion, an average of 156 weeks.] | Mean change from Baseline (Day 1) in MMT 12 over the duration of the study |
| Secondary | Change from baseline in standard vital signs (respiratory rate) | From Baseline (Day 1) through study completion, an average of 156 weeks.] | Incidence of clinically significant changes in vital signs (respiratory rate) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06450886
GET https://conductscience.org/api/trials/v1/NCT06450886/registered