Fibrodysplasia Ossificans ProgressivaPhase 2FALKONNCT05039515
A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).
A Phase 2 study testing IPN60130 in people with Fibrodysplasia Ossificans Progressiva, run by Clementia Pharmaceuticals Inc. at 25 sites in 14 countries.
Trial summary
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Fibrodysplasia Ossificans Progressiva
- What is being tested?
- IPN60130
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 25 sitesin 14 countries
- Study dates
- 1 Dec 2021to 27 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must be at least 5 years of age, to be confirmed (entry for younger paediatric participants <15 years of age will only be once safety in adult and older paediatric participants ≥15 years of age has been established) at the time of signing the informed participant/parent consent and, for participants who are minors, age-appropriate assent.
- Participants must be at least 15 years of age at the time of signing the informed participant/parent consent for the main study and, for participants who are minors, age-appropriate assent
- Participants must be clinically diagnosed with FOP, with the R206H ACVR1 mutation or other FOP variants associated with progressive HO.
- Participants must have disease progression in the preceding year of the screening visit.
- Participants who have participated in a prior clinical study using another investigational product for the treatment of FOP may be enrolled after a washout of at least 5 half-lives of the other investigational product. Participants with prior treatment such as, but not limited to, imatinib, isotretinoin, garetosmab, or palovarotene may be enrolled 30 days after discontinuation or after washout of at least 5 half-lives, whichever is longer.
- Washout period for palovarotene is 30 days
Show all 13Show fewer
- Washout period for garetosmab is 4 months
- Participants must be able to perform pulmonary function tests adequately and reliably.
- Participants must be able to have an adequate echocardiography assessment at screening for evaluation of left ventricular structure and function as defined by the protocol.
- Participants must be accessible for treatment and follow-up and be able to undergo all study procedures. Participants living at distant locations from the investigational site must be able and willing to travel to a site for the initial and all on-site follow-up visits. Participants must be able to undergo low-dose WBCT (excluding head) without sedation.
- Body weight ≥10 kg.
- Abstinent or using two highly effective forms of birth control. Females must also have a negative blood or urine pregnancy test prior to administration of study drug.
- Participants must be capable of giving written, signed, and dated informed participant/parent consent; and for participants who are minors, age-appropriate assent and/or legal guardian consent (performed according to local regulations)
Who cannot join
- Participants with complete heart block and left bundle branch block on screening electrocardiogram.
- Participants with screening echocardiography showing septal or left ventricular free wall thickness >12 mm for adult participants or a z-score >3 compared with population norms for children and adolescent participants or left ventricular ejection fraction (LVEF) <50%.
- Participants with severe mitral or tricuspid regurgitation on echocardiography at screening.
- Participants with significant underlying lung disease requiring supplementary oxygen or forced vital capacity <35% of predicted at screening.
- Participants with uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, immunologic, psychiatric, or another significant disease as judged by the investigator.
- Participants with severe hepatic impairment.
Show all 15Show fewer
- Concomitant medications that are strong inhibitors (including grapefruit juice) or inducers (including St John's Wort) of cytochrome P450 (CYP) 3A4 activity; or kinase inhibitors such as imatinib.
- Prior use in the past year and concomitant use of bisphosphonates for participants in the PET-CT sub study.
- Concurrent participation in another interventional clinical study, or a noninterventional study with radiographic measures or invasive procedures (e.g. collection of blood or tissue samples).
- Amylase or lipase >2× the upper limit of normal (ULN) or with a history of chronic pancreatitis.
- Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5×ULN.
- Participants with hematologic abnormalities:
- Hgb<10g/dL
- Platelets<75,000/mm3
- WBC<2000/mm3
Trial locations and contacts
25 sites in 14 countries.
25 sites in 14 countries
United States4 sites
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
The Perelman School of Medicine - The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco (UCSF)
San Francisco, California, 94143
China4 sites
Children's Hospital Capital Institute of Pediatrics (CIP)
Beijing
Peking Union Medical College Hospital
Beijing
Shangai Children Medical Center
Shanghai
Tongi University - Tongi Hospital
Shanghai
Japan3 sites
Nagoya University Hospital
Nagoya
Aichi Children's Health and Medical Center
Ōbu
The University of Tokyo Hospital
Tokyo
Canada2 sites
University of Alberta, Alberta Health Services (AHS)
Edmonton
University Health Network (UHN), Toronto General Hospital (TGH)
Toronto
France2 sites
Groupe Hospitalier Necker Enfants Malades
Paris, 75015
Hopital Lariboisiere
Paris
Spain2 sites
Hospital Universitario Ramon y Cajal
Pozuelo de Alarcón, 28224
Hospital Universitario Y Politecnico La Femerge
Valencia, 46026
Portugal1 site
Hospital Center Lisbon North, E.P.E- Hospital Santa Maria
Lisbon
About this study
Official title: A Phase 2 Study to Assess the Efficacy and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva in Male and Female Paediatric and Adult Participants.
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility (ankyloses) of major joints with cumulative and irreversible loss of movement and disability.
This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO volume compared with placebo (a dummy treatment) in adult and paediatric participants with FOP. It will be assessed by a scan (provides internal images of the body) called low dose Whole Body Computed Tomography (WBCT), excluding head.
Adults and participants 5 years of age or older are also eligible for a sub study to evaluate HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron Emission Tomography-Computed Tomography ([18F]NaF PET-CT ).
Read the detailed description
Note on Primary Completion Date and Results Disclosure:
The Primary Completion Date (PCD) reflects the date when data collection is completed for all primary outcomes, as defined in the Final Rule (42 CFR Part 11). In this study, safety outcomes are designated as primary and collected through the end of study.
Therefore the PCD has been updated to align with this definition. The interim analyses will proceed per the protocol and SAP. Results will be disclosed in line with applicable regulatory timelines.
- Conditions
- Fibrodysplasia Ossificans Progressiva
- Being tested
- IPN60130, Placebo
- Medical subject headings
- Myositis Ossificans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPN60130Drug
Also called Fidrisertib
Immediate-release capsule containing high dose of the drug substance.
IPN60130Drug
Also called Fidrisertib
Immediate-release capsule containing low dose of the drug substance.
PlaceboDrug
Placebo will be supplied as powder filled hard capsules
| Study group | Role | What they receive |
|---|---|---|
| IPN60130 high dosage | Experimental | Oral capsule, swallowed whole or sprinkled onto food, once daily Receives: Drug: IPN60130 |
| IPN60130 low dosage | Experimental | Oral capsule, swallowed whole or sprinkled onto food, once daily Receives: Drug: IPN60130 |
| Placebo | Placebo comparator | Oral capsule, swallowed whole or sprinkled onto food, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized change in HO volume as assessed by low-dose WBCT (excluding the head) in treated participants receiving IPN60130 compared with placebo.
Measured: From baseline to 12 months
Incidence of Adverse Events / Serious Adverse Events (AEs/SAE)
Measured: From baseline until the end of study (63 months)
Change from baseline in clinically significant abnormal values in laboratory parameters (haematology, biochemistry, and urinalysis)
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.
Measured: From baseline until the end of study (63 months)
Change from baseline in physical examination findings
Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator.
Measured: From baseline until the end of study (63 months)
Change from baseline in clinically significant vital signs
Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be graded by the investigator.
Measured: From baseline until the end of study (63 months)
Change from baseline in clinically significant Electrocardiogram (ECG) readings
Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be graded by the investigator.
Measured: From baseline until the end of study (63 months)
Secondary outcomes (14)
Change in HO volume of new HO lesions as detected by WBCT in participants receiving IPN60130 compared with placebo recipients
Measured: From baseline up to 12 months
Change in number of HO lesions by WBCT in participants receiving IPN60130 compared with placebo recipients
Measured: From baseline up to 12 months
Flare-up rate and number of flare-up days in participants receiving IPN60130 compared with placebo recipients
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
Measured: From baseline up to 12 months
The number of body regions with new HO in participants receiving IPN60130 compared with placebo recipients
Measured: From baseline up to 12 months
Change in pain intensity
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)
Measured: From baseline up to 12 months
The proportion of participants with any new HO in participants receiving IPN60130 compared with placebo recipients
Measured: From baseline up to 12 months
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)
Measured: From baseline up to 60 months
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
Measured: From baseline up to 60 months
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
Measured: From baseline up to 60 months
Pharmacokinetic (PK) parameter: Cmax of IPN60130
Cmax is defined as the maximum observed concentration of IPN60130
Measured: From baseline up to Month 24
PK parameter: AUC of IPN60130
AUC is defined as the concentration of drug over time.
Measured: Every 6 months up to Month 24
PK parameter: Ctrough of IPN60130
Ctrough is defined as the plasma concentration at the end of the dosing interval.
Measured: Every 6 months up to Month 24
PK parameter: Cmin of IPN60130
Cmin is defined as the minimum observed concentration of IPN60130
Measured: Every 6 months up to Month 24
Assessment of the exposure-response relationship
The exposure-response relationship will be assessed by modelling using relevant efficacy and safety parameters
Measured: From baseline up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Dec 2021
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Why it stopped: Following the planned FALKON Part A primary analysis, the study did not meet its primary endpoint of reducing heterotopic ossification (HO) volume compared with placebo and met predefined futility criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrodysplasia Ossificans ProgressivaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clementia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039515
- Sponsor's protocol ID
- D-CA-60130-452
- Other IDs
- 2020-002858-24, 2024-511469-13-00
- Acronym
- FALKON
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Efficacy and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva in Male and Female Paediatric and Adult Participants.
- ClinicalTrials.gov ID
- NCT05039515
- Acronym / sponsor ID
- FALKON / D-CA-60130-452
- Conditions
- Fibrodysplasia Ossificans Progressiva
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following the planned FALKON Part A primary analysis, the study did not meet its primary endpoint of reducing heterotopic ossification (HO) volume compared with placebo and met predefined futility criteria.
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Clementia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ipsen
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility (ankyloses) of major joints with cumulative and irreversible loss of movement and disability.
This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO volume compared with placebo (a dummy treatment) in adult and paediatric participants with FOP. It will be assessed by a scan (provides internal images of the body) called low dose Whole Body Computed Tomography (WBCT), excluding head.
Adults and participants 5 years of age or older are also eligible for a sub study to evaluate HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron Emission Tomography-Computed Tomography ([18F]NaF PET-CT ).
Detailed description
Note on Primary Completion Date and Results Disclosure:
The Primary Completion Date (PCD) reflects the date when data collection is completed for all primary outcomes, as defined in the Final Rule (42 CFR Part 11). In this study, safety outcomes are designated as primary and collected through the end of study.
Therefore the PCD has been updated to align with this definition. The interim analyses will proceed per the protocol and SAP. Results will be disclosed in line with applicable regulatory timelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPN60130 high dosage | Experimental | Drug: IPN60130Oral capsule, swallowed whole or sprinkled onto food, once daily |
| IPN60130 low dosage | Experimental | Drug: IPN60130Oral capsule, swallowed whole or sprinkled onto food, once daily |
| Placebo | Placebo comparator | Drug: PlaceboOral capsule, swallowed whole or sprinkled onto food, once daily |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must be at least 5 years of age, to be confirmed (entry for younger paediatric participants <15 years of age will only be once safety in adult and older paediatric participants ≥15 years of age has been established) at the time of signing the informed participant/parent consent and, for participants who are minors, age-appropriate assent.
- Participants must be at least 15 years of age at the time of signing the informed participant/parent consent for the main study and, for participants who are minors, age-appropriate assent
- Participants must be clinically diagnosed with FOP, with the R206H ACVR1 mutation or other FOP variants associated with progressive HO.
- Participants must have disease progression in the preceding year of the screening visit.
- Participants who have participated in a prior clinical study using another investigational product for the treatment of FOP may be enrolled after a washout of at least 5 half-lives of the other investigational product. Participants with prior treatment such as, but not limited to, imatinib, isotretinoin, garetosmab, or palovarotene may be enrolled 30 days after discontinuation or after washout of at least 5 half-lives, whichever is longer.
Key exclusion criteria (15 listed)
- Participants with complete heart block and left bundle branch block on screening electrocardiogram.
- Participants with screening echocardiography showing septal or left ventricular free wall thickness >12 mm for adult participants or a z-score >3 compared with population norms for children and adolescent participants or left ventricular ejection fraction (LVEF) <50%.
- Participants with severe mitral or tricuspid regurgitation on echocardiography at screening.
- Participants with significant underlying lung disease requiring supplementary oxygen or forced vital capacity <35% of predicted at screening.
- Participants with uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, immunologic, psychiatric, or another significant disease as judged by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPN60130Also: FidrisertibImmediate-release capsule containing high dose of the drug substance. | Drug | IPN60130 high dosage |
| IPN60130Also: FidrisertibImmediate-release capsule containing low dose of the drug substance. | Drug | IPN60130 low dosage |
| PlaceboPlacebo will be supplied as powder filled hard capsules | Drug | Placebo |
Primary outcome
Annualized change in HO volume as assessed by low-dose WBCT (excluding the head) in treated participants receiving IPN60130 compared with placebo.
Time frame: From baseline to 12 months
Incidence of Adverse Events / Serious Adverse Events (AEs/SAE)
Time frame: From baseline until the end of study (63 months)
Change from baseline in clinically significant abnormal values in laboratory parameters (haematology, biochemistry, and urinalysis)
Time frame: 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.
Change from baseline in physical examination findings
Time frame: 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.
Change from baseline in clinically significant vital signs
Time frame: 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.
Change from baseline in clinically significant Electrocardiogram (ECG) readings
Time frame: 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.
14 secondary outcomes
Change in HO volume of new HO lesions as detected by WBCT in participants receiving IPN60130 compared with placebo recipients
Time frame: From baseline up to 12 months
Change in number of HO lesions by WBCT in participants receiving IPN60130 compared with placebo recipients
Time frame: From baseline up to 12 months
Flare-up rate and number of flare-up days in participants receiving IPN60130 compared with placebo recipients
Time frame: From baseline up to 12 months
The number of body regions with new HO in participants receiving IPN60130 compared with placebo recipients
Time frame: From baseline up to 12 months
Change in pain intensity
Time frame: From baseline up to 12 months
The proportion of participants with any new HO in participants receiving IPN60130 compared with placebo recipients
Time frame: From baseline up to 12 months
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)
Time frame: From baseline up to 60 months
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
Time frame: From baseline up to 60 months
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
Time frame: From baseline up to 60 months
Pharmacokinetic (PK) parameter: Cmax of IPN60130
Time frame: From baseline up to Month 24
PK parameter: AUC of IPN60130
Time frame: Every 6 months up to Month 24
PK parameter: Ctrough of IPN60130
Time frame: Every 6 months up to Month 24
PK parameter: Cmin of IPN60130
Time frame: Every 6 months up to Month 24
Assessment of the exposure-response relationship
Time frame: From baseline up to 60 months
Results and safety
The study was stopped early (reason given: Following the planned FALKON Part A primary analysis, the study did not meet its primary endpoint of reducing heterotopic ossification (HO) volume compared with placebo and met predefined futility criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
25 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPN60130 in people with Fibrodysplasia Ossificans Progressiva, run by Clementia Pharmaceuticals Inc. at 25 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, China, Japan, Canada, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following the planned FALKON Part A primary analysis, the study did not meet its primary endpoint of reducing heterotopic ossification (HO) volume compared with placebo and met predefined futility criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized change in HO volume as assessed by low-dose WBCT (excluding the head) in treated participants receiving IPN60130 compared with placebo. (time frame: From baseline to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.