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

Lumos Pharma

Status and phase

Begins enrollment in 6 months

Phase 3

Conditions

Growth Hormone Deficiency (GHD)

Treatments

Drug: LUM-201

Study type

Interventional

Funder types

Industry

Identifiers

NCT07129759

LUM-201-11

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

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.