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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: PPC-06 400 mg BID; Drug: Placebo; Drug: PPC-06 400 mg QD; Drug: PPC-06 600 mg

• Registration Number: NCT03421197
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-01-23
• Study Start: 2018-01-25
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Results First Submitted: 2021-02-26
• Results First Submitted QC: 2021-04-17
• Results First Posted: 2021-05-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPC-06 400 mg BID	PPC-06 400 mg BID	Tepilamide Fumarate 400 mg twice per day
Placebo BID	Placebo	White placebo tablet to mimic Tepilamide Fumarate
PPC-06 400 mg QD	PPC-06 400 mg QD	Tepilamide Fumarate 400 mg once per day
PPC-06 600 mg BID	PPC-06 600 mg	Tepilamide Fumarate 600 mg twice per day

Primary Outcome Measures

Name	Time	Method
Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24	End of Week 24	The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index (PASI-75) The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1	End of Week 24	The Percentage of subjects who achieve the Investigator's Global Assessment (IGA) score of clear or almost clear (IGA score 0 or 1); Score Grade Definition 0 Clear: No signs of psoriasis; 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling; 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions; 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques; 4. Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions; A lower score on this scale at the end of the study indicates an improvement in the disease condition.

Trial Locations

Locations (74)

Site 144; 🇺🇸 Glendale, Arizona, United States

Site 167; 🇺🇸 Phoenix, Arizona, United States

Site 158; 🇺🇸 Phoenix, Arizona, United States

Site 170; 🇺🇸 Tempe, Arizona, United States

Site 157; 🇺🇸 Bryant, Arkansas, United States

Site 125; 🇺🇸 Rogers, Arkansas, United States

Site 133; 🇺🇸 Fountain Valley, California, United States

Site 107; 🇺🇸 Fremont, California, United States

Site 121; 🇺🇸 Fresno, California, United States

Site 153; 🇺🇸 Fullerton, California, United States

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