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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01646567




Registration number
NCT01646567
Ethics application status
Date submitted
11/07/2012
Date registered
20/07/2012
Date last updated
11/07/2014

Titles & IDs
Public title
SHP-141C in Plaque Type Psoriasis
Scientific title
A Double-Blind, Within-Subject Randomised, Placebo-Controlled, Proof of Concept, Comparison Study of SHP-141C Topical Cream in Psoriasis, Using the Microplaque Assay.
Secondary ID [1] 0 0
SHP-141C-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Type Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHP-141C
Treatment: Drugs - Placebo to SHP-141C
Treatment: Drugs - Betamethasone Valerate
Treatment: Drugs - Calcipotriol

Experimental: SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate - A 100 mg dose of SHP-141C cream at three concentrations (0.5%, 1.0% and 2.0%), a matched placebo cream and two reference treatments: Calcipotriol 0.005% cream and Betamethasone Valerate 0.02% cream, applied topically to a selected plaque on each subject, six times per week over 28 days for a total of 24 doses.


Treatment: Drugs: SHP-141C
Topical Cream

Treatment: Drugs: Placebo to SHP-141C
Placebo Topical Cream

Treatment: Drugs: Betamethasone Valerate
Topical cream, 0.02%

Treatment: Drugs: Calcipotriol
Topical cream, 0.005%
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Local Plaque Severity Index (LPSI)
Timepoint [1] 0 0
Baseline, day 15, day 33
Secondary outcome [1] 0 0
The number of patients with adverse events
Timepoint [1] 0 0
daily to and including Day33

Eligibility
Key inclusion criteria
1. Mild to moderate chronic plaque-type psoriasis.

2. psoriasis of at least one year.

3. Stable disease for at least two weeks prior to the commencement of study treatment.

4. One nominated target lesions must have areas of at least 86 x 57 mm2.

5. BMI of less than 35 kg/m2. -
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Dermatological Conditions

- Subjects with erythrodermic, guttate, palmar, plantar or generalised pustular
forms of psoriasis.

- Subjects with scalp, palmar or plantar psoriasis only.

- Subjects with any skin condition other than psoriasis, in particular eczema,
cutaneous infections, significant sun damage or an inherited skin disorder (other
than psoriasis).

2. Concurrent Medical Conditions

- History of clinically significant intercurrent disease of any type (other than
psoriasis).

- A history of moderate or severe asthma during the last 10 years.

- Major chronic inflammatory disease .

- Congenital immunodeficiency or cancer prone syndrome.

- History of abnormal bleeding tendencies or thrombophlebitis, or a history of
Hepatitis B, Hepatitis C or HIV infection.

- History of malignancy (other than adequately treated skin carcinoma or
carcinoma-in-situ of the cervix).

3. Laboratory Status

- Any evidence of organ dysfunction, which is confirmed on re-examination to be
clinically significant (i.e. in the opinion of the Medical Officer would
jeopardise the safety of the subject or impact on the validity of the study
results),

- A creatinine clearance of less than 75 mL/min.

- Liver function test > 1.5 x upper limit of normal other than an isolated
bilirubin.

- Hepatitis B surface antigen, Hepatitis C antibody, HIV antibodies.

4. Treatment with any of the following within 4 weeks prior to the commencement of study
treatment and for the duration of the study:

- Systemic retinoids.

- Immunosuppressant agents (e.g. methotrexate, cyclosporine, azathioprine,
thioguanine prednisone, prednisolone, hydroxyurea or mycophenolate mofetil).

- Phototherapy or photochemotherapy.

- High potency topical corticosteroids.

- "Alternative medicine" treatments for psoriasis.

- Prolonged sun exposure or tanning bed use, which may in the opinion of the
Investigator, modify disease activity.

5. Topical treatment of the 2 target lesions with any of the following within 2 weeks
prior to commencement of study treatment and for the duration of the study

- Moderate potency topical corticosteroids.

- Vitamin D analogues and topical retinoids.

- Keratolytics, coal tar and dithranol.

6. Concurrent Medications Subjects have received or anticipate receiving a new medicine
(prescription, over-the-counter or herbal), given systemically or topically, within 14
days prior to the start of dosing. Subjects may be enrolled if stable on existing
therapy (having been on it for at least 60 days) as determined by the Principal
Investigator.

7. Hypersensitivity History of allergy and/or hypersensitivity to any of the stated
ingredients of the formulations or other topical agents. A known hypersensitivity to
lignocaine, or all surgical dressings that may be used in the study procedures.

8. Females who are lactating, pregnant or planning to become pregnant.

9. Drug and Alcohol Abuse History of, or current evidence of, abuse of alcohol or any
drug substance, licit or illicit, or positive urine drug and alcohol screen for drugs
of abuse and alcohol.

10. Psychiatric Disorder History of any psychiatric illness which may impair the ability
to provide written informed consent

11. Participation in a research study within 30 days of the start of dosing.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
TetraLogic Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety, tolerability and clinical activity of the
SHP-141C topical cream formulations in patients with plaque type psoriasis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01646567
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Foley
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01646567