Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency

NCT ID: NCT07129759

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-30
• Study Completion Date: 2030-02-28

Brief Summary

This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.

Conditions

Growth Hormone Deficiency (GHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LUM-201

Group Type: EXPERIMENTAL

LUM-201

Intervention Type: DRUG

1.6 mg/kg/day, administered orally once daily

Interventions

LUM-201

1.6 mg/kg/day, administered orally once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Parent/caregiver must be willing to provide written informed consent, and the subject must sign the assent, as applicable.
• Subject must have successfully completed 12 months of participation in the LUM-201 Phase 3 GHD trial, and be eligible for continuation of treatment, pending all other enrollment criteria are met.
• Subject who is sexually active must use an acceptable form of contraception.
• Subject must be eligible for the Day 1 visit as confirmed by the Investigator.

Exclusion Criteria

• Subject has a medical or genetic condition that, in the opinion of the Investigator and/or MMs, adds unwarranted risk to use of LUM-201.
• Pregnancy.
• Subject has planned or is receiving current long-term treatment with medications known to prolong the QT interval or act as substrates, inducers, or inhibitors of the cytochrome system cytochrome P450 type 3A4 that metabolizes LUM-201 (see Appendix 6 for list of example medications). Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the Investigator in consultation with the MMs.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumos Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lumos Pharma

Role: CONTACT

clinical.trials@lumos-pharma.com

515-598-2921

Other Identifiers

LUM-201-11

Identifier Type: -

Identifier Source: org_study_id