A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Lumos Pharma
Study ID
NCT05796440
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Growth Hormone Deficiency

Eligibility Criteria

Sex
ALL
Age
5 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • LUM-201 — DRUG
    Administered orally once daily

Study Details

This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.

Key Dates

Start date
Aug 1, 2023
Status verified
Feb 2024
Primary completion
Mar 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LUM-201 (1.6 mg/kg/day)

Primary Outcome Measure

Incidence of treatment-emergent adverse events [ Time Frame: Day 1 to Month 36 ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-
UMass Memorial Medical CenterWorcesterMassachusetts01655-
Children's Mercy HospitalKansas CityMissouri64111-
University of South CarolinaCharlestonSouth Carolina29425-
Texas Tech University Health Sciences CenterAmarilloTexas79106-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IAUMass Memorial Medical Center· Worcester, MAChildren's Mercy Hospital· Kansas City, MOUniversity of South Carolina· Charleston, SCTexas Tech University Health Sciences Center· Amarillo, TXSeattle Children's Hospital· Seattle, WA

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