WHO ICTRP trial
A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study…
JPRN-jRCT2051230127 · Japan Primary Registries Network (JPRN) · Recruiting
Key facts
| Trial ID | JPRN-jRCT2051230127 |
|---|---|
| Public title | A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared With Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive With Systemic Sclerosis |
| Scientific title | The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against… |
| Primary sponsor | Ageishi Yuji |
| Registry | Japan Primary Registries Network (JPRN) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Austria;Japan;Belgium;Japan;Canada;Japan;China;Japan;France;Japan;Germany;Japan;Hungary;Japan;India;Japan;Israel;Japan;Italy;Japan;Mexico;Japan;Netherlands;Japan;Poland;Japan;Romania;Japan;South… |
| Conditions | Systemic Sclerosis, Scleroderma |
| Interventions | Approximately 306 eligible participants will be randomized on Day 1 in a 1:1 ratio to receive either anifrolumab 120 mg SC QW. Beginning with Week 52, all subjects will receive anifrolumab 120 mg SC QW for 52 weeks. |
| Registration date | Nov 11, 2023 |
| Target size | 32 |
| Secondary IDs | NCT05925803 |
| Registry page | jrct.niph.go.jp |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: