Trial · NCT05027802
A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.
NCT05027802, Phase 3, Completed, Ipsen; results first posted 2025-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. Trials, record NCT05027802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05027802
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.
- NCT number
- NCT05027802
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 61 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Fibrodysplasia Ossificans Progressiva (FOP)
- Interventions
- Palovarotene
- First posted
- 2021-08-30
- Last updated
- 2025-06-22
- Other registries' IDs
- eudract:2021-002244-70
- Results first posted
- 2025-06-13
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With All Treatment-emergent Adverse Events (TEAEs), Serious and Non-serious Treatment-emergent Adverse Events and Serious and Non-serious Treatment-related Treatment-emergent Adverse Events | From signing the informed consent form (Day 1) up to 30 days post last dose, approximately 32 months | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or significant medical event. A TEAE was defined as any AE that occurred after signing the informed consent form of this study or an ongoing AE from the parent study with a worsening in severity or relationship to the study treatment following transition to this study. |
| Secondary | Change From the Inclusion Visit in Cumulative Analogue Joint Involvement Scale (CAJIS) Total Score at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The CAJIS is an objective measure of joint movement completed by the investigator to document total joint involvement. This scale assesses functional disability by categorizing range of motion across 12 joints (both right and left shoulder, elbow, wrist, hip, knee and ankle joints) and 3 body regions (cervical spine, thoracic/lumbar spine and jaw), with each joint/region assessed as: 0=normal (\<10% deficit); 1=partially impaired (10% to 90% deficit) and 2=functionally ankylosed (\>90% deficit). The CAJIS total score is calculated as the sum of the scores of all joints/regions and ranges from 0 (no involvement) to 30 (maximally involved). Higher score indicated worse outcome. The Inclusion Visit was the first study visit (Day 1) and first administration of palovarotene in this study. |
| Secondary | Change From the Inclusion Visit in the Use of Assistive Devices and Adaptations (Aids) for Daily Living at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The use of assistive devices and adaptations (aids) for daily living was collected using the FOP assistive devices assessment at each visit. Assistive devices and adaptations include mobility aids, eating tools, personal care tools, bathroom aids and devices, bedroom aids and devices, home adaptions, work environment adaptions, technology adaptions, sports and recreation adaptions, school adaptions and medical therapies for daily living. The mean of total number of assistive devices and adaptations for daily living being used is presented. The Inclusion Visit was the first study visit (Day 1) and first administration of palovarotene in this study. |
| Secondary | Change From the Inclusion Visit in Percentage of Worst Score Using the Adult Form of the Fibrodysplasia Ossificans Progressiva Physical Function Questionnaire (FOP-PFQ) at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The FOP-PFQ is a disease-specific patient-reported outcome measure of physical impairment; includes 28 questions related to activities of daily living and physical performance scored on a scale of 1 to 5 with lower scores indicating that participant has more difficulty completing those tasks. Total score, upper extremities subscore and mobility subscore is calculated as follows: total score: sum of the scores from each question (range 28 to 140); upper extremities subscore: sum of the scores from 15 questions (questions 1-12, 14, 25 and 26; range 15 to 75); mobility subscore: the sum of the scores from 13 questions (questions 13, 15-24, 27 and 28; range 13 to 65). The scores were transformed to reflect a percentage of worst score which ranged from 0% to 100% with 0% indicating the best possible function and 100% (higher score) indicating the worst possible function. Mean is presented. Inclusion Visit was first study visit (Day 1) and first administration of palovarotene in this study. |
| Secondary | Annualized Rate of Healthcare Utilization (HU) in Participants With Fibrodysplasia Ossificans Progressiva | Up to approximately 32 months | Annualized HU rate was defined as the (number of HU during the study/duration of participant participation in the study in days) \* 365.25. Annualized rate for total health care services utilized is presented. |
| Secondary | Change From the Inclusion Visit in Percent Predicted Forced Vital Capacity (FVC) at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | Lung function parameters including FVC were obtained by spirometry. The Inclusion Visit was the first study visit (Day 1) and first administration of palovarotene in this study. |
| Secondary | Change From the Inclusion Visit in Percent Predicted Forced Expiratory Volume in One Second (FEV1) at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | Lung function parameters including FEV1 were obtained by spirometry. The Inclusion Visit was the first study visit (Day 1) and first administration of palovarotene in this study. |
| Secondary | Change From the Inclusion Visit in Predicted FEV1/FVC Ratio at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The ratio of FEV1 to FVC was calculated. Lung function parameters were obtained by spirometry. The Inclusion Visit was the first study visit (Day 1) and first administration of palovarotene in this study. |
| Secondary | Change From the Inclusion Visit in Percent Predicted Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The DLCO test provides information on the efficiency of gas transfer from alveolar air into the bloodstream. The Inclusion Visit was the first study visit (Day 1) and first administration of palovarotene in this study. |
| Secondary | Change From the Inclusion Visit in Physical and Mental Function Using Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The PROMIS Global Health Scale is a patient-reported outcome measure of physical and mental function. The adult form (developed for participants \>=15 years old) was used for all participants,consists of 10 questions from which 2 scores are calculated: global physical health score (GPH) and global mental health (GMH) score, each ranging from 4 (worse health) to 20 (better health). GPH score:sum of scores from Questions 3, 6, 7 and 8 and GMH score:sum of scores from Questions 2, 4, 5 and 10.These scores were converted to a T-score whose distributions were standardized such that value of 50 represented average (mean) for general population and increments of +/- 10 points represented +/- 1 standard deviation away from the norm.Higher T-scores indicated better physical/mental health. A T-score \<50 indicated worse health than general population, while a T-score \>50 indicated better health. Inclusion Visit was first study visit (Day 1) and first administration of palovarotene in this study. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With All Treatment-emergent Adverse Events (TEAEs), Serious and Non-serious Treatment-emergent Adverse Events and Serious and Non-serious Treatment-related Treatment-emergent Adverse Events | From signing the informed consent form (Day 1) up to 30 days post last dose, approximately 32 months | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From the Inclusion Visit in Cumulative Analogue Joint Involvement Scale (CAJIS) Total Score at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. Only those participants with data collected at specified timepoints are reported. | score on a scale | MEAN |
| SECONDARY | Change From the Inclusion Visit in the Use of Assistive Devices and Adaptations (Aids) for Daily Living at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. Only those participants with data collected at specified timepoints are reported. | number of aids | MEAN |
| SECONDARY | Change From the Inclusion Visit in Percentage of Worst Score Using the Adult Form of the Fibrodysplasia Ossificans Progressiva Physical Function Questionnaire (FOP-PFQ) at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. Only those participants with data collected at specified timepoints are reported. | percentage of score | MEAN |
| SECONDARY | Annualized Rate of Healthcare Utilization (HU) in Participants With Fibrodysplasia Ossificans Progressiva | Up to approximately 32 months | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. Only those participants with data collected at specified timepoints are reported. | HU per participant year | MEAN |
| SECONDARY | Change From the Inclusion Visit in Percent Predicted Forced Vital Capacity (FVC) at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. Only those participants with data collected at specified timepoints are reported. | percent predicted FVC | MEAN |
| SECONDARY | Change From the Inclusion Visit in Percent Predicted Forced Expiratory Volume in One Second (FEV1) at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. Only those participants with data collected at specified timepoints are reported. | percent predicted FEV1 | MEAN |
| SECONDARY | Change From the Inclusion Visit in Predicted FEV1/FVC Ratio at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. Only those participants with data collected at specified timepoints are reported. | ratio | MEAN |
| SECONDARY | Change From the Inclusion Visit in Percent Predicted Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. Only those participants with data collected at specified timepoints are reported. | percent predicted DLCO | MEAN |
| SECONDARY | Change From the Inclusion Visit in Physical and Mental Function Using Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale at Months 6, 12, 18, 24 and 30 | Inclusion Visit (Day 1) and Months 6, 12, 18, 24 and 30 | The FAS/safety set included all participants who received at least 1 dose of palovarotene in this study. Only those participants with data collected at specified timepoints are reported. | T-score | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group137
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants With All Treatment-emergent Adverse Events (TEAEs), Serious and Non-serious Treatment-emergent Adverse Events and Serious and Non-serious Treatment-related Treatment-emergent Adverse Events | Palovarotene | All TEAEs | 54 | Participants | |
Number of Participants With All Treatment-emergent Adverse Events (TEAEs), Serious and Non-serious Treatment-emergent Adverse Events and Serious and Non-serious Treatment-related Treatment-emergent Adverse Events | Palovarotene | Serious TEAEs | 9 | Participants | |
Number of Participants With All Treatment-emergent Adverse Events (TEAEs), Serious and Non-serious Treatment-emergent Adverse Events and Serious and Non-serious Treatment-related Treatment-emergent Adverse Events | Palovarotene | Non-serious TEAEs | 53 | Participants | |
Number of Participants With All Treatment-emergent Adverse Events (TEAEs), Serious and Non-serious Treatment-emergent Adverse Events and Serious and Non-serious Treatment-related Treatment-emergent Adverse Events | Palovarotene | Serious treatment-related TEAEs | 1 | Participants | |
Number of Participants With All Treatment-emergent Adverse Events (TEAEs), Serious and Non-serious Treatment-emergent Adverse Events and Serious and Non-serious Treatment-related Treatment-emergent Adverse Events | Palovarotene | Non-serious treatment-related TEAEs | 38 | Participants | |
| Change From the Inclusion Visit in Cumulative Analogue Joint Involvement Scale (CAJIS) Total Score at Months 6, 12, 18, 24 and 30 | Palovarotene | Month 6 | 0.6 | Standard Deviation 1.3 | score on a scale |
| Change From the Inclusion Visit in Cumulative Analogue Joint Involvement Scale (CAJIS) Total Score at Months 6, 12, 18, 24 and 30 | Palovarotene | Month 12 | 1.1 | Standard Deviation 2.0 | score on a scale |
| Change From the Inclusion Visit in Cumulative Analogue Joint Involvement Scale (CAJIS) Total Score at Months 6, 12, 18, 24 and 30 | Palovarotene | Month 18 | 1.5 | Standard Deviation 2.3 | score on a scale |
| Change From the Inclusion Visit in Cumulative Analogue Joint Involvement Scale (CAJIS) Total Score at Months 6, 12, 18, 24 and 30 | Palovarotene | Month 24 | 1.5 | Standard Deviation 2.6 | score on a scale |
| Change From the Inclusion Visit in Cumulative Analogue Joint Involvement Scale (CAJIS) Total Score at Months 6, 12, 18, 24 and 30 | Palovarotene | Month 30 | 2.0 | Standard Deviation 4.7 | score on a scale |
1 to 10 of 137Source ClinicalTrials.gov
See all 137 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palovarotene | 61 | |
| Overall Study | Received Treatment | Palovarotene | 59 | |
| Overall Study | COMPLETED | Palovarotene | 38 | |
| Overall Study | NOT COMPLETED | Palovarotene | 23 |
Source ClinicalTrials.gov
Adverse events39
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Palovarotene | 11 | 59 | 11 |
| other | Upper respiratory tract infection | Infections and infestations | Palovarotene | 5 | 59 | 5 |
| other | Localised infection | Infections and infestations | Palovarotene | 3 | 59 | 3 |
| other | Nasopharyngitis | Infections and infestations | Palovarotene | 3 | 59 | 4 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Palovarotene | 14 | 59 | 16 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Palovarotene | 5 | 59 | 6 |
| other | Eczema | Skin and subcutaneous tissue disorders | Palovarotene | 4 | 59 | 5 |
| other | Erythema | Skin and subcutaneous tissue disorders | Palovarotene | 4 | 59 | 4 |
| other | Rash | Skin and subcutaneous tissue disorders | Palovarotene | 4 | 59 | 6 |
| other | Skin exfoliation | Skin and subcutaneous tissue disorders | Palovarotene | 4 | 59 | 4 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palovarotene | 2 | 59 |
| Total, other adverse events | Palovarotene | 45 | 59 |
| Total, serious adverse events | Palovarotene | 9 | 59 |
Source ClinicalTrials.gov
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/NCT05027802
GET https://conductscience.org/api/trials/v1/NCT05027802/results?page=2