Efficacy & safety study of weekly MOD-4023 in GHD - CP-4-006 - V1.0
Research type
Research Study
Full title
Study title: A phase 3, open-label, randomized, multicenter, 12 months , efficacy and safety study of weekly MOD-4023 compared to daily Genotropin - therapy in pre-pubertal children with growth hormone deficiency
IRAS ID
209462
Contact name
Director of Clinical Affairs
Contact email
Sponsor organisation
KCR CRO GmbH
Eudract number
2016-003874-42
Clinicaltrials.gov Identifier
79,745, IND number
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
This is a research study comparing the effects of a long acting weekly growth hormone (MOD4023) compared with Genotropin, a licensed daily growth hormone. The study will be conducted over a 12 month period.
After a screening period lasting up to 8 weeks, patients meeting the eligibility criteria, will be randomly in a 1:1 ratio to MOD-4023 (investigational treatment, 0.66 mg/kg/week) or growth hormone Genotropin (reference therapy, 0.034 mg/kg/daily which is equivalent to 0.24 mg/kg/week divided
equally to 7 injections over a week) for 12 months. To compare the efficacy and safety of weekly MOD- 4023 to daily growth hormone, Genotropin. A daily growth hormone (genotropin) will be used to compare to MOD 4023.
MOD-4023, the investigational medication, that is similar to the natural growth hormone from the body, but is slightly changed so that its action in the body lasts longer allowing for weekly (instead of daily) subcutaneous (under the skin) injections. This is convenient for children since it would decrease the
number of injections needed.
MOD-4023 has already been tested in other clinical studies and to date has been well tolerated in adult healthy volunteers, and adult and children patients suffering from growth hormone deficiency.
Girls between 3 years of age and under the age of 11 (i.e. not yet the age of 10 years and 364 days) and boys 3 years of age and under the age of 12 (i.e. not yet the age of 11 years and 364 days) with growth hormone deficiency are suitable to take part in this study. All participants need to have a screening visit
to make sure they are eligible for this study.
Approximately 150-180 sites in 30-40 countries worldwide will participate in this study.
An independent and external Data and Safety Monitoring Board (DSMB) will review the key safety data approximately every 6 months or on ad hoc basis.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0040
Date of REC Opinion
5 Apr 2017
REC opinion
Further Information Favourable Opinion