Trial · NCT05039515
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized change in HO volume as assessed by low-dose WBCT (excluding the head) in treated participants receiving IPN60130 compared with placebo. | From baseline to 12 months | |
| Primary | Incidence of Adverse Events / Serious Adverse Events (AEs/SAE) | From baseline until the end of study (63 months) | |
| Primary | Change from baseline in clinically significant abnormal values in laboratory parameters (haematology, biochemistry, and urinalysis) | From baseline until the end of study (63 months) | Percentage of participants with clinically significant change in laboratory parameters (biochemistry, hematology and urinalysis) will be reported. The clinical significance will be graded by the investigator. |
| Primary | Change from baseline in physical examination findings | From baseline until the end of study (63 months) | Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator. |
| Primary | Change from baseline in clinically significant vital signs | From baseline until the end of study (63 months) | Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be graded by the investigator. |
| Primary | Change from baseline in clinically significant Electrocardiogram (ECG) readings | From baseline until the end of study (63 months) | Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be graded by the investigator. |
| Secondary | Change in HO volume of new HO lesions as detected by WBCT in participants receiving IPN60130 compared with placebo recipients | From baseline up to 12 months | |
| Secondary | Change in number of HO lesions by WBCT in participants receiving IPN60130 compared with placebo recipients | From baseline up to 12 months | |
| Secondary | Flare-up rate and number of flare-up days in participants receiving IPN60130 compared with placebo recipients | From baseline up to 12 months | The rate and the number of flare-up days, the flare-up being confirmed by the Investigator, will be compared between participants treated with IPN60130 and those treated with Placebo at Month 12 |
| Secondary | The number of body regions with new HO in participants receiving IPN60130 compared with placebo recipients | From baseline up to 12 months | |
| Secondary | Change in pain intensity | From baseline up to 12 months | Assessed in participants ≥13 years old with the Numeric pain rating scale (NRS) and in participants \<13 years old with Wong Baker Faces Pain Scale (FPS) |
| Secondary | The proportion of participants with any new HO in participants receiving IPN60130 compared with placebo recipients | From baseline up to 12 months | |
| Secondary | Change from baseline in HO volume as detected by WBCT in participants receiving IPN60130 compared with placebo recipients and with participants receiving the standard of care in the Natural history study (NHS) | From baseline up to 60 months | |
| Secondary | Change from baseline in Cumulative Analogue Joint Involvement Scale for FOP (CAJIS) by treatment arm compared with placebo recipients and participants receiving the standard of care in the NHS across all available timepoints | From baseline up to 60 months | |
| Secondary | Change in the FOP Physical Function Questionnaire (FOP-PFQ) by treatment arm compared with placebo recipients and participants receiving the standard of care in the NHS from baseline across all available timepoints | From baseline up to 60 months | |
| Secondary | Pharmacokinetic (PK) parameter: Cmax of IPN60130 | From baseline up to Month 24 | Cmax is defined as the maximum observed concentration of IPN60130 |
| Secondary | PK parameter: AUC of IPN60130 | Every 6 months up to Month 24 | AUC is defined as the concentration of drug over time. |
| Secondary | PK parameter: Ctrough of IPN60130 | Every 6 months up to Month 24 | Ctrough is defined as the plasma concentration at the end of the dosing interval. |
| Secondary | PK parameter: Cmin of IPN60130 | Every 6 months up to Month 24 | Cmin is defined as the minimum observed concentration of IPN60130 |
| Secondary | Assessment of the exposure-response relationship | From baseline up to 60 months | The exposure-response relationship will be assessed by modelling using relevant efficacy and safety parameters |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05039515/registered