18 and older, any sex, with Purpura, Thrombocytopenic, Idiopathic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Response in Platelet CountPrimary· Up to 12 weeks.
This outcome measure presents number of patients with a response in platelet count. Response was defined as:
\[A\] An increase in platelet count by greater than 20 x 10\^9/L from baseline at any time-point between Week 1 and Week 12, and \[B\] Platelet count above 50 x 10\^9/L at any time point between Week 1 and Week 12 with no rescue therapy.
Baseline was defined as the platelet count at Visit 2 before administration of BI 655064. In case the patient fulfilled only one of the conditions, he/she was considered a non-responder.
No
Group
Value
95% CI
BI 655064 120 mg / 180 mg
5
Yes
Group
Value
95% CI
BI 655064 120 mg / 180 mg
1
Number of Subjects With Drug-related Adverse EventsSecondary· From first drug administration until end of the Residual Effect Period (REP), up to 6 weeks.
Number of participants with investigator defined drug-related adverse events (AEs) is reported.
Group
Value
95% CI
BI 655064 120 mg / 180 mg
1
Number of Patients Reaching the Cut-off Point for Immune Thrombocytopenic Purpura [ITP]Secondary· Up to 12 weeks.
This outcome measure presents the number of patients reaching the cut-off point for ITP, which was defined as: \[A\] Platelet count ≥ 100 x 10\^9/L at any time point between Week 1 and Week 12.
No
Group
Value
95% CI
BI 655064 120 mg / 180 mg
6
Yes
Group
Value
95% CI
BI 655064 120 mg / 180 mg
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration until end of the Residual Effect Period (REP), up to 6 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT03385564 — An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
· Phase 2
· completed
NCT02331277 — Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers
· Phase 1
· completed
NCT01917916 — Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers
· Phase 1
· completed
NCT01751776 — Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of B
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 15 March 2024
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/NCT02009761.