Trial · NCT06508021
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
NCT06508021, Phase 2, Phase 3, Active not recruiting, Ashibio Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP). Trials, record NCT06508021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06508021
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
- NCT number
- NCT06508021
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 92 participants, estimated
- Lead sponsor
- Ashibio Inc
- Conditions
- Fibrodysplasia Ossificans Progressiva
- Interventions
- Andecaliximab, Placebo, Andecaliximab
- First posted
- 2024-07-18
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of New HO Lesions as Assessed by WBCT-LH [Whole body, Computerized Tomography (CT), not including the head (less head)] | Week 27 and 53 | Low dose WBCT-LH (whole body CT less head) is used to create detailed images of soft tissues and bones. |
| Secondary | Percent change from baseline in Na18F standardized uptake value maximum (SUVmax) of up to 7 individual HO lesion(s) per participant active at baseline as assessed by Na18F PET/CT (Part 1a). | Week 14 | SUV max is the SUV of the most intense voxel within a region of interest. |
| Secondary | Change in HO volume over time as assessed by WBCT-LH [Whole body, Computerized Tomography (CT), not including the head (less head)] (Part 1a) | Week 14 | Low dose WBCT-LH (whole body CT less head) is used to create detailed images of soft tissues and bones. In Part 1a, the WBCT-LH scan will be acquired as part of the PET/CT scan at baseline and Week 14. |
| Secondary | Change in HO volume over time as assessed by WBCT-LH [Whole body, Computerized Tomography (CT), not including the head (less head)] | Week 27 and 53 | |
| Secondary | Number of days during which a flare-up is experienced by the participant as reported by the participant | Week 14, 27 and 53 | Flare-up defined as having at least two of the following symptoms: pain, soft tissue swelling, warmth, redness, joint stiffness, or decreased range of motion. |
| Secondary | Number of flare-ups as reported by the participant | Week 14, 27 and 53 | |
| Secondary | Number of flare-ups as reported by the participant and confirmed by the Principal Investigator | Week 14, 27 and 53 | |
| Secondary | Change in patient joint involvement as assessed by Investigator using Cumulative Analog Joint Involvement Scale (CAJIS) | Week 27 and 53 | CAJIS is a clinician assessment of 15 major joints; each major joint rated normal unaffected (0), affected (1), or completely functionally ankylosed (2). The total score ranges from 0 to 30. |
| Secondary | Change in patient quality of life as assessed by the EuroQol 5 dimensions questionnaire with a 5-level scale (EQ-5D-5L) | Week 27 and 53 | EQ-5D-5L measures: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Week 27 and 53 | Number of participants with Treatment-Emergent Adverse Events (AE) (TEAEs), i.e., adverse events not present at baseline or exacerbation of a pre-existing condition during the on-treatment period will be reported. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT06508021
GET https://conductscience.org/api/trials/v1/NCT06508021/registered