A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Exploratory Efficacy of FPP003 Vaccine in Subjects with Psoriasis.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000599178

Enrollment

Registered

2019-04-17

Start date

2019-04-17

Completion date

2022-06-06

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 4 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.

Interventions

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) Cohort 4 - 9 participants will receive one subcutaneous injection of FPP003 vaccine at 15.0 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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;

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;

Outcome results