Home › Trials › NCT05070845

Evaluating PF-06835375 for treating Primary Immune Thrombocytopenia

AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA

Phase 2 Interventional Pfizer · NCT05070845

This study is testing a new treatment called PF-06835375 to see if it can help adults with primary immune thrombocytopenia by increasing their platelet counts.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment91 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorPfizer Industry-sponsored
Locations31 sites (Greenville, North Carolina and 30 other locations)
Trial IDNCT05070845 on ClinicalTrials.gov

What this trial studies

This Phase 2, open-label study investigates the safety and efficacy of PF-06835375 in adults with primary immune thrombocytopenia (ITP). Participants with persistent or chronic ITP will receive subcutaneous injections of the treatment over a specified period to assess its impact on platelet counts. The study aims to determine whether the treatment can effectively increase platelet levels by targeting specific immune cells. The design includes multiple cohorts receiving different doses to evaluate the optimal response.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with persistent or chronic primary ITP and experiencing low platelet counts.

Not a fit: Patients with recent severe bleeding events or those who have undergone splenectomy within the last three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve platelet counts in patients suffering from primary immune thrombocytopenia.

How similar studies have performed: Other studies involving B-cell depleting agents have shown promise in treating similar conditions, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Greenville, North Carolina and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary Immune ThrombocytopeniaITPplatelets
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.