A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2014-000290-39-DK
• Date of registration: 22/01/2015
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency
• Scientific title: A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2
• Date of first enrolment: 22/01/2015
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000290-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Denmark, European Union, Japan, Sweden, United Kingdom

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent
2. Adult growth hormone deficiency diagnosed = 6 months (defined as 180 days) prior to screening
3. Treatment with hGH for at least 6 months at screening
4. If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion criteria:
1. Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:
- Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision
- Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject’s file
2. For patients with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:
- Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as = 365 days) before randomisation. Absence of growth must be documented by two post-surgery MRI or CT scans. The most recent MRI or CT scan must be performed = 9 months (defined as = 270 days) prior to randomisation



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Growth hormone deficiency in adults
MedDRA version: 18.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders

Intervention(s)

Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: N/A
CAS Number: 1338578-34-9
Other descriptive name: NNC0195-0092
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-

Trade Name: Norditropin FlexPro 10 mg
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-

Primary Outcome(s)

Primary end point(s): Incidence of adverse events, including injection site reactions

Main Objective: To evaluate the clinical safety of once weekly dosing of NNC0195-0092 during 26 weeks of treatment in AGHD subjects previously treated with daily hGH

Secondary Objective: To evaluate the degree of treatment satisfaction of once weekly dosing of NNC0195-0092 during 26 weeks of treatment in AGHD subjects previously treated with daily hGH

Timepoint(s) of evaluation of this end point: From baseline to the end of the treatment period (26 weeks)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: From baseline (randomisation) to end of treatment period (26 weeks)

Secondary end point(s): Safety
- Occurrence of anti-NNC0195-0092 antibodies
Efficacy
- Change in Treatment Satisfaction Questionnaire for Medication (TSQM) scores (effectiveness, convenience, and global satisfaction scores)

Secondary ID(s)

NN8640-4043

2014-000290-39-SE

Source(s) of Monetary Support

Novo Nordisk A/S