PsoriasisPhase 2NCT03421197
A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)
A Phase 2 study testing PPC-06 400 mg QD, PPC-06 400 mg BID and PPC-06 600 mg in people with Psoriasis, run by Dr. Reddy's Laboratories Limited at 74 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- PPC-06 400 mg QD, PPC-06 400 mg BID and PPC-06 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 74 sitesUnited States
- Study dates
- 25 Jan 2018to 30 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- PASI score of ≥12
- Total body surface area (BSA) affected by plaque psoriasis of ≥10%
- IGA score of >3
- Must be a candidate for phototherapy and/or systemic therapy for psoriasis.
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
74 sites in 1 country.
74 sites in 1 country
United States74 sites
Site 148
Austin, Texas, 78745
Site 119
Baton Rouge, Louisiana, 70808
Site 118
Beachwood, Ohio, 44122
Site 160
Bellaire, Texas, 77401
Site 157
Bryant, Arkansas, 72022
Site 135
Burien, Washington, 98168
Site 169
Cincinnati, Ohio, 45236
Site 137
Clearwater, Florida, 33761
Site 128
Clinton Township, Michigan, 48038
Site 130
Coral Gables, Florida, 33134
Site 133
Fountain Valley, California, 92708
Site 107
Fremont, California, 94538
Site 121
Fresno, California, 93720
Site 129
Fridley, Minnesota, 55432
Site 153
Fullerton, California, 92835
Site 144
Glendale, Arizona, 85308
Site 143
Hialeah, Florida, 33012
Site 145
Hialeah, Florida, 33012
Site 181
Hialeah, Florida, 33012
Site 108
High Point, North Carolina, 27262
Site 162
Houston, Texas, 77004
Site 102
Houston, Texas, 77056
Site 115
Indianapolis, Indiana, 46256
Site 114
Johnston, Rhode Island, 02919
Site 111
Kansas City, Missouri, 64114
Site 127
Las Vegas, Nevada, 89119
Site 180-
Las Vegas, Nevada, 89148
Site 176
Los Angeles, California, 90057
Site 178
Los Angeles, California, 90057
Site 182
Los Angeles, California, 90057
Site 165
Louisville, Kentucky, 40202
Site 131
Louisville, Kentucky, 40217
Site 142
Louisville, Kentucky, 40241
Site 132
Marietta, Georgia, 30060
Site 149
Miami, Florida, 33014
Site 105
Miami, Florida, 33144
Site 174
Miami, Florida, 33155
Site 164
Miami, Florida, 33175
Site 123
Miami, Florida, 33186
Site 112
Miramar, Florida, 33027
Site 134
Mt. Pleasant, South Carolina, 29464
Site 156
Murrieta, California, 92562
Site 122
Nampa, Idaho, 83651
Site 171
New Albany, Indiana, 47150
Site 126
New Orleans, Louisiana, 70115
Site 172
New Port Richey, Florida, 34655
Site 103
New York, New York, 10012
Site 177
New York, New York, 10075
Site 104
New York, New York, 10155
Site 166
Norfolk, Virginia, 23507
Site 109
Omaha, Nebraska, 68114
Site 152
Orange Park, Florida, 32073
Site 136
Orem, Utah, 84058
Site 139
Overland Park, Kansas, 66215
Site 154
Pembroke Pines, Florida, 33028
Site 167
Phoenix, Arizona, 85018
Site 158
Phoenix, Arizona, 85053
Site 100
Rapid City, South Dakota, 57702
Site 161
Rochester, New York, 14623
Site 125
Rogers, Arkansas, 72758
Site 106
San Antonio, Texas, 78229
Site 101
San Antonio, Texas, 78281
Site 141
San Diego, California, 92123
Site 155
Santa Rosa, California, 95405
Site 124
Savannah, Georgia, 31406
Site 147
Spokane, Washington, 99202
Site 146
Stony Brook, New York, 11790
Site 159
Sugar Land, Texas, 77479
Site 110
Sweetwater, Florida, 33172
Site 150
Tampa, Florida, 33609
Site 113
Tampa, Florida, 33624
Site 170
Tempe, Arizona, 85283
Site 179
Wheaton, Illinois, 60189
Site 116
Wilmington, North Carolina, 28405
About this study
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)
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.
Read the 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:
- PPC-06 400 mg once daily (QD)
- PPC-06 400 mg BID
- PPC-06 600 mg BID
- Placebo BID The maximum study duration for each subject will be approximately 29 weeks.
- Conditions
- Psoriasis
- Being tested
- PPC-06 400 mg QD, PPC-06 400 mg BID, PPC-06 600 mg, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPC-06 400 mg QDDrug
Also called Tepilamide Fumarate 400 mg
Tepilamide Fumarate 400 mg tablet once per day
PPC-06 400 mg BIDDrug
Also called Tepilamide Fumarate 400 mg
Tepilamide Fumarate tablets 400 mg twice per day
PPC-06 600 mgDrug
Also called Tepilamide Fumarate 600 mg
Tepilamide Fumarate tablets 600 mg twice per day
PlaceboDrug
Also called Placebo tablets twice per day
white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
| Study group | Role | What they receive |
|---|---|---|
| PPC-06 400 mg QD | Experimental | Tepilamide Fumarate 400 mg once per day Receives: Drug: PPC-06 400 mg QD |
| PPC-06 400 mg BID | Experimental | Tepilamide Fumarate 400 mg twice per day Receives: Drug: PPC-06 400 mg BID |
| PPC-06 600 mg BID | Experimental | Tepilamide Fumarate 600 mg twice per day Receives: Drug: PPC-06 600 mg |
| Placebo BID | Placebo comparator | White placebo tablet to mimic Tepilamide Fumarate Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving Psoriasis Area and Severity Index (PASI) - 75 at the 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.
Measured: End of Week 24
Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1
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
- Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling
- Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions
- Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques
- 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.
Measured: End of Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start25 Jan 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Srinivas Sidgiddi, MD, Study director, Dr. Reddy's Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421197
- Sponsor's protocol ID
- PPC-06-CD-004
- Status last verified
- Mar 2022
- First submitted
- 23 Jan 2018
- Last updated
- 1 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03421197
- Acronym / sponsor ID
- PPC-06-CD-004
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- PPC-06 400 mg once daily (QD)
- PPC-06 400 mg BID
- PPC-06 600 mg BID
- Placebo BID The maximum study duration for each subject will be approximately 29 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| PPC-06 400 mg QD | Experimental | Drug: PPC-06 400 mg QDTepilamide Fumarate 400 mg once per day |
| PPC-06 400 mg BID | Experimental | Drug: PPC-06 400 mg BIDTepilamide Fumarate 400 mg twice per day |
| PPC-06 600 mg BID | Experimental | Drug: PPC-06 600 mgTepilamide Fumarate 600 mg twice per day |
| Placebo BID | Placebo comparator | Drug: PlaceboWhite placebo tablet to mimic Tepilamide Fumarate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
- Must be a candidate for phototherapy and/or systemic therapy for psoriasis.
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPC-06 400 mg QDAlso: Tepilamide Fumarate 400 mgTepilamide Fumarate 400 mg tablet once per day | Drug | PPC-06 400 mg QD |
| PPC-06 400 mg BIDAlso: Tepilamide Fumarate 400 mgTepilamide Fumarate tablets 400 mg twice per day | Drug | PPC-06 400 mg BID |
| PPC-06 600 mgAlso: Tepilamide Fumarate 600 mgTepilamide Fumarate tablets 600 mg twice per day | Drug | PPC-06 600 mg BID |
| PlaceboAlso: Placebo tablets twice per daywhite tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets | Drug | Placebo BID |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivas Sidgiddi, MD study director
Dr. Reddy's Laboratories, Inc
74 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PPC-06 400 mg QD, PPC-06 400 mg BID and PPC-06 600 mg in people with Psoriasis, run by Dr. Reddy's Laboratories Limited at 74 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24 (time frame: End of Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.