Terminated PHASE1/PHASE2 INTERVENTIONAL 4-arm NCT03866577

Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients

A 4-part Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of M254 in Healthy Volunteers and in Patients With Immune Thrombocytopenic Purpura

Sponsor: Momenta Pharmaceuticals, Inc.

Conditions Immune Thrombocytopenic Purpura (ITP)

Interventions Biological: M254 Intravenous immunoglobulin (IVIg) Placebo

Updated 27 times since 2019 Last updated: May 26, 2025 Started: Dec 21, 2018 Primary completion: Jun 9, 2021 Completion: Jun 9, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study was terminated based on Sponsor decision.

This PHASE1/PHASE2 trial investigates Immune Thrombocytopenic Purpura (ITP) and is currently terminated or withdrawn. Momenta Pharmaceuticals, Inc. leads this study, which shows 27 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed.

Status Flow

Change History

27 versions recorded

Jan 2026 — Present [monthly]

Terminated PHASE1/PHASE2
Sep 2025 — Present [monthly]

Terminated PHASE1/PHASE2
Jun 2025 — Sep 2025 [monthly]

Terminated PHASE1/PHASE2
Sep 2024 — Jun 2025 [monthly]

Terminated PHASE1/PHASE2
Aug 2024 — Sep 2024 [monthly]

Terminated PHASE1/PHASE2

▶ Show 22 earlier versions

Jul 2024 — Aug 2024 [monthly]

Terminated PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Jun 2024 — Jul 2024 [monthly]

Terminated PHASE1_PHASE2
Aug 2023 — Jun 2024 [monthly]

Terminated PHASE1_PHASE2
Jul 2022 — Aug 2023 [monthly]

Terminated PHASE1_PHASE2
Sep 2021 — Jul 2022 [monthly]

Terminated PHASE1_PHASE2

Status: Recruiting → Terminated
Apr 2021 — Sep 2021 [monthly]

Recruiting PHASE1_PHASE2
Mar 2021 — Apr 2021 [monthly]

Recruiting PHASE1_PHASE2
Jan 2021 — Mar 2021 [monthly]

Recruiting PHASE1_PHASE2
Dec 2020 — Jan 2021 [monthly]

Recruiting PHASE1_PHASE2
Oct 2020 — Dec 2020 [monthly]

Recruiting PHASE1_PHASE2
Sep 2020 — Oct 2020 [monthly]

Recruiting PHASE1_PHASE2
Jul 2020 — Sep 2020 [monthly]

Recruiting PHASE1_PHASE2
May 2020 — Jul 2020 [monthly]

Recruiting PHASE1_PHASE2
Mar 2020 — May 2020 [monthly]

Recruiting PHASE1_PHASE2
Feb 2020 — Mar 2020 [monthly]

Recruiting PHASE1_PHASE2
Jan 2020 — Feb 2020 [monthly]

Recruiting PHASE1_PHASE2
Dec 2019 — Jan 2020 [monthly]

Recruiting PHASE1_PHASE2
Nov 2019 — Dec 2019 [monthly]

Recruiting PHASE1_PHASE2
Oct 2019 — Nov 2019 [monthly]

Recruiting PHASE1_PHASE2
Aug 2019 — Oct 2019 [monthly]

Recruiting PHASE1_PHASE2
May 2019 — Aug 2019 [monthly]

Recruiting PHASE1_PHASE2
Apr 2019 — May 2019 [monthly]

Recruiting PHASE1_PHASE2

First recorded

Dec 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Momenta Pharmaceuticals, Inc.

Data source: Momenta Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Barcelona, Spain , Burgos, Spain , Chorzów, Poland , Cleveland, United States , Debrecen, Hungary , Durham, United States , Groningen, Netherlands , Kaposvár, Hungary , Los Angeles, United States , Lublin, Poland and 17 more locations