Last reviewed · How we verify
NCT05408715: ROCKET
A Natural History Study in Children With a Type II Collagen Disorder With Short Stature
trial testing Natural History Study in SEDC in 60 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Innoskel |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 29 June 2022 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across France, Spain |
Drugs / interventions tested
- Natural History Study
Conditions studied
- SEDC — all drugs for SEDC →
- Hypochondrogenesis — all drugs for Hypochondrogenesis →
- Semd, Strudwick Type — all drugs for Semd, Strudwick Type →
- Kniest Dysplasia — all drugs for Kniest Dysplasia →
Sponsor
Innoskel
Who can join
Under 12, any sex, with SEDC or Hypochondrogenesis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There are relatively few data available on type II collagen disorders, and evidence is lacking on the disease course in relation to symptoms and development of complications, the level of actual disease burden over time as well as data to support identification of possible risk factors. This study aims to build a natural history data set through collection of a number of clinical, imaging, and laboratory assessments that may be specific predictors of type II collagen disorder progression and clinical outcome. Having a type II collagen disorder natural history data set can inform potential efficacy endpoints and biomarkers for future clinical trials. This natural history study will follow up to 60 individuals diagnosed with a type II collagen disorder for up to 3 years. Visits will be conducted every 3 months for the first year and then every 6 months, during which several assessments will be performed in order to learn about the natural course of the disease, including changes in clinical and functional outcomes, imaging and biofluid biomarkers. Some of the study activities include: a physical exam, height measurements, vision and breathing tests and x-ray. A blood sample will be collected once or twice each year. Most of the information collected, the tests done, and the schedule of visits in this study are the same as recommended for regular care of children with a type II collagen disorder.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05408715
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Natural History Study
Trials testing the same drug.
- NCT05100810 — Angelman Syndrome Natural History Study-FAST UK · unknown
- NCT05809635 — Study of BEST1 Vitelliform Macular Dystrophy · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05408715 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Innoskel
- Last refreshed: 2 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05408715.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing