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Trial registered on ANZCTR


Registration number
ACTRN12619000599178
Ethics application status
Approved
Date submitted
4/04/2019
Date registered
17/04/2019
Date last updated
19/11/2019
Date data sharing statement initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Exploratory Efficacy of FPP003 Vaccine in Subjects with Psoriasis.
Scientific title
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Exploratory Efficacy of FPP003 Vaccine in Subjects with Psoriasis.
Secondary ID [1] 297480 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 311684 0
Condition category
Condition code
Skin 310313 310313 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cohort 1 - 4 participants will receive one subcutaneous injection of FPP003 vaccine at 0.5 mg on three occasions (Day 1, Day 15, and Day 29).
Cohort 2 - 4 participants will receive one subcutaneous injection of FPP003 vaccine at 1.5 mg on three occasions (Day 1, Day 15, and Day 29).
Cohort 3 - 9 participants will receive one subcutaneous injection of FPP003 vaccine at 5.0 mg on three occasions (Day 1, Day 15, and Day 29)
A safety review committee consisting of an independent medical monitor, investigator, and other members of the investigational team will review safety data include adverse events, clinical laboratory results, and vital signs through Day 8 prior to dosing of the next cohort.
The selected doses for a given cohort may also be adjusted by the investigator or safety review committee if three or more subjects in a given cohort experience any severe or serious adverse events that are at least possibly related to study drug. Additional cohorts may be enrolled after consultation between the sponsor and the investigator.
Intervention code [1] 313739 0
Treatment: Drugs
Comparator / control treatment
Placebo (Sodium acetate buffer containing sodium chloride)

Cohort 1 - 2 participants will receive one subcutaneous injection of Placebo on three occasions (Day 1, Day 15, and Day 29).
Cohort 2 - 2 participants will receive one subcutaneous injection of Placebo on three occasions (Day 1, Day 15, and Day 29).
Cohort 3 - 3 participants will receive one subcutaneous injection of Placebo on three occasions (Day 1, Day 15, and Day 29)
Control group
Placebo

Outcomes
Primary outcome [1] 319206 0
Safety and tolerability of escalating doses of the FPP003 vaccine administered as a subcutaneous injection in adults with psoriasis compared with placebo This will be assessed by reviewing the incidence and severity of adverse events (AE), Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions, assessing local injection site reactions, and clinically significant changes from baseline in: laboratory evaluations (haematology, biochemistry, urinalysis), electrocardiograms (ECG), vital signs, and physical examinations.
Timepoint [1] 319206 0
Baseline (Day 1 pre-dose) through Day 120

ECG at Baseline (Day 1 pre-dose) and Day 29
Vital signs at Baseline (Day 1 pre-dose) and on Days 8, 15, 29, 60, 90, and 120
Clinical laboratory assessments at Baseline (Day 1 pre-dose) and on Days 8, 15, 29, 60, 90, and 120
Injection site reaction assessment at Baseline (Day 1 pre-dose) and on Days 8, 15, and 29.
Symptom directed physical exam at Baseline (Day 1 pre-dose) and on Days 8, 15, 29, 60, 90, and 120
Secondary outcome [1] 367296 0
Serum PK concentration of the FPP003 vaccine
Timepoint [1] 367296 0
At baseline (Day 1 pre-dose) and, 5, 15, 30, 60, and 120 minutes after FPP003 administration on Day 1 and Day 29.
Secondary outcome [2] 367299 0
Pharmacodynamic effect (immunological response) following escalating doses of the FPP003 vaccine compared to placebo in adults with psoriasis This will be assessed by changes to serum IL-17A titre at Day 8, 15, 29, 60, 90 and 120 compared to baseline (Day 1 pre-dose)
Timepoint [2] 367299 0
Changes at Days 8, 15, 29, 60, 90, and 120 compared to baseline (Day 1 pre-dose)
Secondary outcome [3] 369182 0
Evaluate the efficacy of escalating doses of the FPP003 vaccine in adults with psoriasis compared to placebo based on changes from baseline to Psoriasis area severity index (PASI); • Proportion of subjects to achieve: - PASI 90 (i.e., 90% reduction from baseline PASI score); - PASI 75 (i.e., 75% reduction from baseline PASI score); - PASI 50 (i.e., 50% reduction from baseline PASI score); - PASI 25 (i.e., 25% reduction from baseline PASI score);
Timepoint [3] 369182 0
PASI scores at baseline (Day 1 pre-dose) and on Days 8, 15, 29, 60, 90 and 120
Secondary outcome [4] 369183 0
Evaluate the efficacy of escalating doses of the FPP003 vaccine in adults with psoriasis compared to placebo based on changes from baseline to % body surface area (BSA) of psoriasis;
Timepoint [4] 369183 0
Percent BSA of psoriasis at baseline (Day 1 pre-dose) and on Days 15, 29, 60, 90 and 120
Secondary outcome [5] 369184 0
Evaluate the efficacy of escalating doses of the FPP003 vaccine in adults with psoriasis compared to placebo based on changes from baseline to Dermatology Life Quality Index (DLQI)
Timepoint [5] 369184 0
DLQI at baseline (Day 1 pre-dose) and on Day 120
Secondary outcome [6] 369185 0
Evaluate the efficacy of escalating doses of the FPP003 vaccine in adults with psoriasis compared to placebo based on changes from baseline to biomarkers in serum and skin biopsy samples. Change in serum IL-17A and other relevant biomarker levels (including IL-17F, IL-22, IL-23, hBD-2, liopcaline-2) at Day 120 compared to baseline (Day 1 pre-dose); • Change in skin IL-17A and other relevant biomarker levels (including IL-17F, IL-22, IL-23, hBD-2, liopcaline-2) from skin biopsy samples collected at baseline (Day 1 pre-dose) and Day 120
Timepoint [6] 369185 0
Serum IL-17A titre at baseline (Day 1 pre-dose) and on Days 8, 15, 29, 60, 90, and 120.
Serum biomarkers at baseline (Day 1 pre-dose) and on Days 60, 90, and 120.
Skin biopsy at baseline (Day 1 pre-dose) and on Day 120.

Eligibility
Key inclusion criteria
1. Male or female aged 18 to 75 years (inclusive) at screening;
2. Body mass index (BMI) of greater than 18.5 kg/m2 and less than 38 kg/m2 at screening;
3. History of plaque-type psoriasis for greater than or equal to 6 months;
4. Plaque-type psoriasis based on PASI score greater than or equal to 5 at both the screening and baseline visits;
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of non-plaque psoriasis i.e., pustular, erythrodermic psoriasis;
2. Presence of other skin condition other than psoriasis, in particular eczema, skin infections or an inherited skin disorder (other than psoriasis) that would interfere with the ability to perform study assessments;
3. History or evidence of a clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator and medical monitor or designee, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;

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)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
NSW,SA
Recruitment hospital [1] 13240 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [2] 15188 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 25798 0
5000 - Adelaide
Recruitment postcode(s) [2] 28497 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 302047 0
Commercial sector/Industry
Name [1] 302047 0
FunPep Co., Ltd
Address [1] 302047 0
151-0051 No. 7 Mizuho Building 3F
5-8-4 Sendagaya Shibuya-ku
Tokyo
Country [1] 302047 0
Japan
Primary sponsor type
Commercial sector/Industry
Name
FunPep Co. Ltd.
Address
151-0051 No. 7 Mizuho Building 3F
5-8-4 Sendagaya Shibuya-ku
Tokyo
Country
Japan
Secondary sponsor category [1] 301856 0
Commercial sector/Industry
Name [1] 301856 0
Avance Clinical Pty Ltd
Address [1] 301856 0
Level 1, 2 Ann Nelson Drive
Thebarton, SA 5031
Country [1] 301856 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302729 0
Bellberry Human Research Ethics Committee B (TGA HREC Code EC00419)
Ethics committee address [1] 302729 0
123 Glen Osmond Road
Eastwood, SA 5063
Ethics committee country [1] 302729 0
Australia
Date submitted for ethics approval [1] 302729 0
23/01/2019
Approval date [1] 302729 0
25/02/2019
Ethics approval number [1] 302729 0
2019-01-055

Summary
Brief summary
Psoriasis is an immune-mediated disease that causes raised, red, scaly patches to appear on the skin as a result of a sped-up skin production process. The typical life cycle of a skin cell is 1 month (www.healthline.com/health/psoriasis). Typically, skin cells grow deep in the skin and slowly rise to the surface and eventually fall off. In people with psoriasis, this production process may occur in just a few days resulting in rapid overproduction and build-up of skin cells.
This study is investigating a new vaccine called FPP003 which is being developed to treat patients with moderate - severe psoriasis. This study will investigate the safety and tolerability of FPP003. It will also look at the pharmacokinetics (how much of the drug remains in the blood at certain timepoints) of the drug and how effective it is with escalating dose levels. These investigations will be compared with placebo under the same conditions.
This study will be conducted in 3 successive, dose escalated, cohorts. In each cohort, participants will receive a subcutaneous dose of the study drug (FPP003 or placebo) on Day 1, Day 15 and Day 29. The study will be divided into a screening phase lasting up to 28 days. The total duration of the study for participants completing the study is about 5 months, with a total of 8 visits to the study unit.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91186 0
Dr Catherine Reid
Address 91186 0
CMAX Clinical Research
Level 5, 18a North Terrace
Adelaide, SA 5000
Country 91186 0
Australia
Phone 91186 0
+61 08 8363 7433
Fax 91186 0
Email 91186 0
creid@internode.on.net
Contact person for public queries
Name 91187 0
Dr Catherine Reid
Address 91187 0
CMAX Clinical Research
Level 5, 18a North Terrace
Adelaide, SA 5000
Country 91187 0
Australia
Phone 91187 0
+61 08 8363 7433
Fax 91187 0
Email 91187 0
creid@internode.on.net
Contact person for scientific queries
Name 91188 0
Dr Catherine Reid
Address 91188 0
CMAX Clinical Research
Level 5, 18a North Terrace
Adelaide, SA 5000
Country 91188 0
Australia
Phone 91188 0
+61 08 8363 7433
Fax 91188 0
Email 91188 0
creid@internode.on.net

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results