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Trial registered on ANZCTR


Registration number
ACTRN12606000040561
Ethics application status
Approved
Date submitted
24/01/2006
Date registered
27/01/2006
Date last updated
18/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The safety and efficacy of Cpn10 in psoriasis
Scientific title
A single centre, double blind, parallel group, three arm, Phase IIa clinical trial designed to assess the efficacy and safety of Cpn10 administered as twice weekly intravenous injections in subjects with plaque psoriasis.
Secondary ID [1] 234 0
CBio Ltd: CBIO 2005-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 1002 0
Condition category
Condition code
Skin 1078 1078 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Cpn10 7.5mg twice per week
Cpn10 10mg twice per week
given as intravenous injections over 12 weeks
Intervention code [1] 858 0
Treatment: Drugs
Comparator / control treatment
Cpn10 5mg twice per week
Control group
Dose comparison

Outcomes
Primary outcome [1] 1443 0
Efficacy will be measured by a 75 % improvement in disease extent and severity, as measured by the PASI score (PASI-75 response).
Timepoint [1] 1443 0
After 12 weeks.
Secondary outcome [1] 2553 0
1. PASI 75 response
Timepoint [1] 2553 0
Anytime up to 12 weeks + 4 weeks follow up.
Secondary outcome [2] 2554 0
2. PASI 50 response
Timepoint [2] 2554 0
Anytime up to 12 weeks + 4 weeks follow up.
Secondary outcome [3] 2555 0
3. PASI 90 response
Timepoint [3] 2555 0
At week 12 or anytime.
Secondary outcome [4] 2556 0
4. Physician Global Assessment
Timepoint [4] 2556 0
Anytime up to 12 weeks + 4 weeks follow up.
Secondary outcome [5] 2557 0
5. Mean % PASI reduction
Timepoint [5] 2557 0
Anytime up to 12 weeks + 4 weeks follow up.
Secondary outcome [6] 2558 0
6. Cytokine production by PBMC stimulation in vitro
Timepoint [6] 2558 0
Anytime up to 8 weeks.

Eligibility
Key inclusion criteria
1. Have been diagnosed with plaque psoriasis for at least 6 months. 2. Have plaque psoriasis covering > 10 % body surface area (BSA). 3. Have a PASI score of > 12 at the screening visit. 4. Have a Physician’s Global Assessment (PGA) Score of at least ‘moderate’ at the screening visit. 5. Have psoriasis that is not controlled by current therapies. 6. Weigh less than 120 kg. 7. Sexually active women of child bearing potential must agree to use a medically reliable method of preventing conception for the duration of the study, unless surgically sterile or post menopausal. Sexually active men whose partners are of childbearing potential must agree to use a medically reliable method of preventing conception for the duration of the study, unless surgically sterile. 8. Be willing to hold sun exposure reasonably constant and to avoid use of tanning booths during the study. Narrowband UVB (NBUVB) treatment for psoriasis is permitted prior to and during the course of this study. 9. Have provided written informed consent to participate in the trial.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have guttate, erythrodermic or pustular psoriasis as the sole or predominant form of psoriasis.2. History of allergic or anaphylactic reactions to Cpn10.3. Have a clinically significant psoriasis flare during screening or at the time of enrolment.4. Have a history of or ongoing bacterial, viral, fungal or atypical mycobacterial infection.5. Have a history of opportunistic infections (e.g. systemic fungal infections, parasites) within the preceding 6 months.6. Have a seropositive test to HIV, Hepatitis B or Hepatitis C at screening.7. Female who is lactating or pregnant (confirmed by a positive serum ?-HCG pregnancy test at screening).8. Subjects with the following laboratory test results at screening:(a) White blood cell (WBC) count <4000/L(b) Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase levels greater than 3 times the upper limit of normal range for the laboratory conducting the test.(c) Serum creatinine > 2 times the upper limit of normal range for the laboratory conducting the test.9. Have a history of active tuberculosis confirmed by a chest X-ray and Quantiferon TB gold testing at screening10. Have been diagnosed with a malignancy or have a history of malignancy within the last 5 years. Subjects with fully excised basal or squamous cell carcinomas may be enrolled.11. Have a diagnosis of hepatic cirrhosis, regardless of the cause or severity.12. Have been admitted to hospital for cardiac disease, stroke or pulmonary disease within the last 12 months13. Have a history of substance abuse within the last 5 years.14. Have a medical condition that in the opinion of the investigator would jeopardise the subject’s safety following exposure to the study drug.15. Have received treatment with the following medications:(a) Immunosuppressive drugs within 28 days prior to study day 0.(b) Prior treatment with the following anti-TNF-alpha agents: infliximab, etanercept or adalumumab(c) Live or killed virus or bacteria vaccines within 14 days of study day 0(d) Other vaccines or allergy desensitisation therapies within 14 days of study day 0(e) Other experimental drugs or treatments within 28 days or 5 half-lives (whichever is longer) prior to study day 0(f) Beta-blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs or lithium. If clinically indicated these medications are allowed but the dosage must be held constant from screening and throughout the trial period.16. Deemed by the investigator to be uncooperative or unsuitable for inclusion into this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sequential codes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked random sequence generated in EXCEL.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1181 0
Commercial sector/Industry
Name [1] 1181 0
CBio Limited
Address [1] 1181 0
85 Brandl St
Eight Mile Plains QLD 4113
Country [1] 1181 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CBio Limited
Address
85 Brandl St
Eight Mile Plains QLD 4113
Country
Australia
Secondary sponsor category [1] 1040 0
None
Name [1] 1040 0
N/A
Address [1] 1040 0
Country [1] 1040 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2497 0
Emeritus Research
Ethics committee address [1] 2497 0
291 Wattletree Rd, Malvern VIC 3144
Ethics committee country [1] 2497 0
Australia
Date submitted for ethics approval [1] 2497 0
Approval date [1] 2497 0
Ethics approval number [1] 2497 0

Summary
Brief summary
Safety and effectiveness of Cpn10 in patients with moderate to severe psoriasis. Three doses of Cpn10 are being trialed. The study personnel performing the assessments, the sponsor and the patient are blinded to which of the three doses are administered.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35277 0
Address 35277 0
Country 35277 0
Phone 35277 0
Fax 35277 0
Email 35277 0
Contact person for public queries
Name 10047 0
Bronwyn Williams
Address 10047 0
CBio Limited
85 Brandl St
Eight Mile Plains QLD 4113
Country 10047 0
Australia
Phone 10047 0
+61 7 38414844
Fax 10047 0
+61 7 38418189
Email 10047 0
bronwyn.williams@cbio.com.au
Contact person for scientific queries
Name 975 0
Dr Dennis Feeney
Address 975 0
CBio Limited
85 Brandl St
Eight Mile Plains QLD 4113
Country 975 0
Australia
Phone 975 0
+61 7 38414844
Fax 975 0
+61 7 38418189
Email 975 0
dennis.feeney@cbio.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary