A double blind, placebo controlled, parallel group study with an open label reference arm to assess the effects of intravenously administered AIN457 on ozone induced neutrophilia compared to placebo and oral corticosteroid in healthy volunteers

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-002854-39-DE
• Date of registration: 04/11/2008
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A double blind, placebo controlled, parallel group study with an open label reference arm to assess the effects of intravenously administered AIN457 on ozone induced neutrophilia compared to placebo and oral corticosteroid in healthy volunteers
• Scientific title: A double blind, placebo controlled, parallel group study with an open label reference arm to assess the effects of intravenously administered AIN457 on ozone induced neutrophilia compared to placebo and oral corticosteroid in healthy volunteers
• Date of first enrolment: 15/01/2009
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002854-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Third arm open label with OCS If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
• Healthy male and female subjects age 18 to 55 years of age. Female subjects of child bearing potential will be excluded.
• Able to produce sputum with normal sputum neutrophil levels at screening (<65% of non-epithelial cells) and are ozone responsive (=50% absolute increase in sputum neutrophils at 24h, visit 3)
• Screening FEV1 at least 80% of predicted.
• Negative latent tuberculosis blood test at screening
• Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
• Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges.
Other inclusion criteria are outlined in the protocol




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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Smokers.
• Treatment with an immunosuppressive agent within the last six months.
• Presence or history of a major chronic inflammatory autoimmune disease like psoriasis, psoriatic arthritis, rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematesus (SLE).

---Full inclusion / exclusion criteria are presented in the protocol---


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

Health Condition(s) or Problem(s) studied

Healthy volunteers

Intervention(s)

Product Code: AIN457
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Prednisolson-ratiopharm® 50 mg Tabletten
Product Name: Prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: • To assess the ability of AIN457 to inhibit ozone-induced airway neutrophilia in induced sputum by evaluating total neutrophil count at 24 hours compared to oral corticosteroid (OCS) and percentage neutrophil count at 24 hours compared to placebo and OCS
• To assess the safety and tolerability of AIN457
• To evaluate the effect of AIN457 on airway function (FEV1, FVC, and FEF25-75) at 4h, 24h, and 48h after the start of the ozone exposure
• To evaluate the pharmacokinetics (PK) of AIN457
• To evaluate the pharmacodynamics (PD) of AIN457 as reflected in serum total IL-17A

Main Objective: • To assess the ability of AIN457 to inhibit ozone-induced airway neutrophilia (total neutrophil cell count in 106/mL) in induced sputum at 24 hours compared to placebo

Primary end point(s): Total neutrophil cell count in millions/mL in induced sputum at 24 hours

Secondary ID(s)

CAIN457A2104