Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05086744
Phase
PHASE2
Status
Terminated

Conditions

  • Cold Agglutinin Disease (CAD)
  • Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Iptacopan — DRUG
    Iptacopan 200 mg BID given orally (capsule)

Study Details

The main purpose of this study was to evaluate the efficacy and safety of iptacopan in participants with autoimmune benign hematological disorders such as primary immune thrombocytopenia and primary cold agglutinin disease.

Key Dates

Start date
Dec 21, 2021
Status verified
Oct 2025
Primary completion
Sep 20, 2023
Completion
May 17, 2024

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iptacopan 200 mg BID
    Iptacopan 200 mg twice daily (BID) in participants with primary ITP and primary CAD

Primary Outcome Measure

Cohort 1 (ITP): Number of Participants With a Clinically Meaningful Response [ Time Frame: Up to 12 weeks (Part A) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Related coverage on Hipa.ai

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies