A prospective randomized, double-blind, placebo-controlled, multi-center phase III study to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult in acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512752-38-00

Acronym

PKRPC001

Enrollment

157

Registered

2024-08-08

Start date

2025-09-09

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjunctive and maintenance treatment to HCT

Brief summary

Relapse-free survival (RFS)

Detailed description

Overall Survival (OS) - mocravimod's effect on OS to that to placebo, RFS at EOS (End-of-study) - to assess the sustained efficacy of moc in comparison to placebo, Survival free from Grade III/IV aGvHD at 12 mo & time to acute GvHD, Survival free from moderate /severe cGvHD at EOS & time to cGvHD, GRFS (GvHD-free, Relapse-free survival at 12 mo and at EOS)

Interventions

DRUGHard capsules containing maize starch

DRUGmicrocrystalline cellulose

DRUGmagnesium stearate

DRUGMocravimod (KRP203)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Relapse-free survival (RFS)	—

Secondary

Measure	Time frame
Overall Survival (OS) - mocravimod's effect on OS to that to placebo, RFS at EOS (End-of-study) - to assess the sustained efficacy of moc in comparison to placebo, Survival free from Grade III/IV aGvHD at 12 mo & time to acute GvHD, Survival free from moderate /severe cGvHD at EOS & time to cGvHD, GRFS (GvHD-free, Relapse-free survival at 12 mo and at EOS)	—

Countries

France, Germany, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026