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A randomized, placebo controlled, investigator and participant-blinded study, investigating safety, tolerability and efficacy of RHH646 in participants with knee osteoarthritis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502821-16-00
Acronym
CRHH646A12201
Enrollment
63
Registered
2023-06-20
Start date
2023-09-01
Completion date
2025-02-11
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

Change from baseline in cartilage volume in the index region of the target knee by MRI at Week 52, Adverse Events (AEs) Electrocardiograms (ECGs) Vital signs Hematology, blood chemistry, urinalysis

Detailed description

RHH646 plasma concentrations, Cmin,ss at Week4 and any other PK parameter as appropriate

Interventions

DRUGPlacebo to RHH646 25 mg hard capsules
DRUGRHH646

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in cartilage volume in the index region of the target knee by MRI at Week 52, Adverse Events (AEs) Electrocardiograms (ECGs) Vital signs Hematology, blood chemistry, urinalysis

Secondary

MeasureTime frame
RHH646 plasma concentrations, Cmin,ss at Week4 and any other PK parameter as appropriate

Countries

Denmark, Germany, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026