A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)

Dr.Reddy's Laboratories

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: PPC-06 400 mg BID; Drug: Placebo; Drug: PPC-06 400 mg QD; Drug: PPC-06 600 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03421197

PPC-06-CD-004

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with moderate-to-severe plaque psoriasis.

Full description

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 in subjects with moderate-to-severe plaque psoriasis. Study subjects will be enrolled at approximately 75 sites in the United States (US).

Approximately 400 subjects who meet the study entry criteria will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms:

1. PPC-06 400 mg once daily (QD)
2. PPC-06 400 mg BID
3. PPC-06 600 mg BID
4. Placebo BID The maximum study duration for each subject will be approximately 29 weeks.

Enrollment: 426 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Generally healthy males or non-pregnant females age ≥18 years at the time of screening (or who have reached the state minimum legal age of consent).

• Stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator or as reported by the subject).

• Severity of disease meeting all 3 of the following criteria prior to randomization (at the Baseline [Day 0] visit):

  1. PASI score of ≥12
  2. Total body surface area (BSA) affected by plaque psoriasis of ≥10%
  3. IGA score of >3

• Must be a candidate for phototherapy and/or systemic therapy for psoriasis.

Exclusion criteria

• Subjects with non-plaque psoriasis (ie, predominantly inverse, erythrodermic, predominantly guttate, or pustular psoriasis).

• Subjects with drug-induced psoriasis or subjects with drug-exacerbated psoriasis that has not resolved within 4 weeks prior to screening.

• Subjects who have received systemic non-biologic psoriasis therapy or phototherapy (including either oral and topical psoralen and ultraviolet A (PUVA) light therapy, ultraviolet B, or self-treatment with tanning beds or therapeutic sunbathing) within 4 weeks prior to the Baseline Visit.

• Subjects who had topical psoriasis treatment within the previous 2 weeks prior to the Baseline Visit.

• Subjects with history of concurrent or recent use of any biologic agent within the following washout periods prior to baseline visit:

  • Etanercept - 35 days
  • Infliximab, adalimumab - 12 weeks
  • Ustekinumab - 24 weeks
  • Any other biologic agent <5 half-lives prior to the Baseline Visit

• Subjects with history of use of any investigational drug within 28 days prior to randomization, or 5 pharmacokinetic/ pharmacodynamic half-lives (whichever is longer).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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426 participants in 4 patient groups, including a placebo group

PPC-06 400 mg QD

Experimental group

Description:

Tepilamide Fumarate 400 mg once per day

Treatment:

Drug: PPC-06 400 mg QD

PPC-06 400 mg BID

Experimental group

Description:

Tepilamide Fumarate 400 mg twice per day

Treatment:

Drug: PPC-06 400 mg BID

PPC-06 600 mg BID

Experimental group

Description:

Tepilamide Fumarate 600 mg twice per day

Treatment:

Drug: PPC-06 600 mg

Placebo BID

Placebo Comparator group

Description:

White placebo tablet to mimic Tepilamide Fumarate

Treatment:

Drug: Placebo