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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421197
Recruitment Status : Completed
First Posted : February 5, 2018
Results First Posted : May 11, 2021
Last Update Posted : April 1, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: PPC-06 400 mg QD Drug: PPC-06 400 mg BID Drug: PPC-06 600 mg Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 24-Week Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate) Extended Release Tablets in Subjects With Moderate-to-Severe Plaque Psoriasis (AFFIRM)
Actual Study Start Date : January 25, 2018
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: PPC-06 400 mg QD
Tepilamide Fumarate 400 mg once per day
 Drug: PPC-06 400 mg QD
Tepilamide Fumarate 400 mg tablet once per day
Other Name: Tepilamide Fumarate 400 mg
Experimental: PPC-06 400 mg BID
Tepilamide Fumarate 400 mg twice per day
 Drug: PPC-06 400 mg BID
Tepilamide Fumarate tablets 400 mg twice per day
Other Name: Tepilamide Fumarate 400 mg
Experimental: PPC-06 600 mg BID
Tepilamide Fumarate 600 mg twice per day
 Drug: PPC-06 600 mg
Tepilamide Fumarate tablets 600 mg twice per day
Other Name: Tepilamide Fumarate 600 mg
Placebo Comparator: Placebo BID
White placebo tablet to mimic Tepilamide Fumarate
 Drug: Placebo
white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Other Name: Placebo tablets twice per day


Outcome Measures
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Primary Outcome Measures :
  1. Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24 [ Time Frame: 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.

  2. Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1 [ Time Frame: 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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421197


Locations
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Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Study Director: Srinivas Sidgiddi, MD Dr. Reddy's Laboratories, Inc
  Study Documents (Full-Text)

Documents provided by Dr. Reddy's Laboratories Limited:
Study Protocol  [PDF] October 26, 2018
Statistical Analysis Plan  [PDF] April 15, 2019

More Information
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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03421197    
Other Study ID Numbers: PPC-06-CD-004
First Posted: February 5, 2018    Key Record Dates
Results First Posted: May 11, 2021
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases