A Phase 2/3, Multicenter, Open-Label Phase Followed by a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children with Hypochondroplasia: ACCEL 2/3

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516822-67-00

Acronym

QBGJ398-304

Enrollment

Registered

2025-07-15

Start date

2025-08-14

Completion date

Unknown

Last updated

2026-01-21

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

Conditions

Hypochondroplasia

Brief summary

ACCEL 2: Change from baseline (BL) in height velocity (HV) at Week 26 (annualized to cm/year). ACCEL 3: Change from BL to Week 52 in AHV compared to placebo.

Detailed description

ACCEL 2: Change from BL in height Z-score (in relation to both HCH and average height tables for age and sex) compared to placebo., ACCEL 3: Change from BL to Week 52 in upper to lower body segment ratio, compared to placebo.

Interventions

DRUGINFIGRATINIB

DRUGPLACEBO

DRUGInfigratinib

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
ACCEL 2: Change from baseline (BL) in height velocity (HV) at Week 26 (annualized to cm/year). ACCEL 3: Change from BL to Week 52 in AHV compared to placebo.	—

Secondary

Measure	Time frame
ACCEL 2: Change from BL in height Z-score (in relation to both HCH and average height tables for age and sex) compared to placebo., ACCEL 3: Change from BL to Week 52 in upper to lower body segment ratio, compared to placebo.	—

Countries

France, Norway, Portugal, Spain, Sweden

Outcome results

None listed

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