Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
ConditionPrimary Immune Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPfizer
About this trial
This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (\>3 months and ≤12 months), or chronic (\>12 months) ITP
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Primary ITP. Ongoing ITP (platelet counts <50 x 109/L) [No severe bleeding within 1 month or during screening] AND Persistent ITP (3 to 12 months) or Chronic ITP >12 months
Disqualifiers
Bleeding event according to the WHO grading scale ≥2 occurring ≤4 weeks prior to screen OR a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy OR require blood or blood products during screening
Splenectomy within 3 months of randomization or planned during the study duration.
Trial design
Design model
Single group
Treatments tested in this trial
PF-06835375
Biological/VaccineCXCR5 inhibitor
Treatment groups
91 Participants
are divided into 4 treatment groupsGroup A: Open Label PF-06835375 dose 1 TreatmentExperimental treatment 1 intervention
Group B: Open Label PF-06835375 dose 2 TreatmentExperimental treatment 1 intervention
Group C: Open Label PF-06835375 dose 3 TreatmentExperimental treatment 1 intervention
Group D: Open Label PF-06835375 dose 4 TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with change from baseline of platelet counts
To evaluate absolute value of platelet count of treated participants
Time frame
baseline through 12 and 16 weeksSecondary outcomes
1
proportion of participants with modified overall response (mOR)
To evaluate the modified overall response of platelet count of treated participants
Time frame
baseline through 12 and 16 weeks2
proportion of participants with complete response (CR)
To evaluate the complete response of platelet count of treated participants
Time frame
baseline through 12 and 16 weeks3
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame
baseline through end of study (Week 20 for cohort 1 and Week 24 for cohorts 2 and 3)4
Proportion of participants with change from baseline of platelet counts
Time frame
baseline to Week 20 and Week 24 Source ClinicalTrials.gov