A Phase 2 interventional study of PPC-06 400 mg QD and PPC-06 400 mg BID in Psoriasis, sponsored by Dr. Reddy's Laboratories Limited. Completed at 74 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by Dr. Reddy's Laboratories Limited · Phase 2, Interventional, and Treatment
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.
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:
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 426 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Dr. Reddy's Laboratories Limited is the lead sponsor of 224 studies on the registry; 2 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Severity of disease meeting all 3 of the following criteria prior to randomization (at the Baseline [Day 0] visit):
Exclusion Criteria:
Subjects with history of concurrent or recent use of any biologic agent within the following prior to baseline visit:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tepilamide Fumarate 400 mg once per day
Drug: PPC-06 400 mg QD
Tepilamide Fumarate 400 mg twice per day
Drug: PPC-06 400 mg BID
Tepilamide Fumarate 600 mg twice per day
Drug: PPC-06 600 mg
White placebo tablet to mimic Tepilamide Fumarate
Drug: Placebo
Tepilamide Fumarate 400 mg tablet once per day
Also known as: Tepilamide Fumarate 400 mg
Tepilamide Fumarate tablets 400 mg twice per day
Also known as: Tepilamide Fumarate 400 mg
Tepilamide Fumarate tablets 600 mg twice per day
Also known as: Tepilamide Fumarate 600 mg
white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Also known as: Placebo tablets twice per day
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.
Time frame: 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 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.
Time frame: End of Week 24
| Milestone | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID |
|---|---|---|---|---|
| Started | 105 | 107 | 107 | 107 |
| Completed | 67 | 68 | 56 | 62 |
| Not completed | 38 | 39 | 51 | 45 |
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.
| percentage of total participants | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID |
|---|---|---|---|---|
| Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24 | 39.7 | 47.2 | 44.3 | 20.0 |
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.
| percentage of total participants | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID |
|---|---|---|---|---|
| Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1 | 35.7 | 41.4 | 44.4 | 22.0 |
Collected over Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PPC-06 400 mg QD | 0/105 (0%) | 3/105 (2.9%) | 30/105 (28.6%) |
| PPC-06 400 mg BID | 0/107 (0%) | 3/107 (2.8%) | 42/107 (39.3%) |
| PPC-06 600 mg BID | 0/106 (0%) | 0/106 (0%) | 68/106 (64.2%) |
| Placebo BID | 0/107 (0%) | 2/107 (1.9%) | 9/107 (8.4%) |
| Event | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID |
|---|---|---|---|---|
| Dyspnoea/Shortness of BreathRespiratory, thoracic and mediastinal disorders | 1/105 | 0/107 | 0/106 | 0/107 |
| DiverticulitisGastrointestinal disorders | 1/105 | 0/107 | 0/106 | 0/107 |
| DiverticulitisInfections and infestations | 1/105 | 0/107 | 0/106 | 0/107 |
| HypersensitivityImmune system disorders | 0/105 | 1/107 | 0/106 | 0/107 |
| Femur fractureInjury, poisoning and procedural complications | 0/105 | 1/107 | 0/106 | 0/107 |
| HypokalaemiaMetabolism and nutrition disorders | 0/105 | 1/107 | 0/106 | 0/107 |
| Cervical cord compressionNervous system disorders | 0/105 | 0/107 | 0/106 | 1/107 |
| Staphylococcal skin infectionInfections and infestations | 0/105 | 0/107 | 0/106 | 1/107 |
| Event | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID |
|---|---|---|---|---|
| DiarrheaGastrointestinal disorders | 7/105 | 19/107 | 24/106 | 5/107 |
| Abdominal PainGastrointestinal disorders | 4/105 | 5/107 | 12/106 | 0/107 |
| NauseaGastrointestinal disorders | 7/105 | 7/107 | 11/106 | 2/107 |
| LymphopeniaBlood and lymphatic system disorders | 4/105 | 4/107 | 10/106 | 0/107 |
| Urinary Tract InfectionInfections and infestations | 3/105 | 1/107 | 6/106 | 2/107 |
| EosinophiliaBlood and lymphatic system disorders | 5/105 | 6/107 | 5/106 | 0/107 |
| Age, Continuous(years) | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID | Total |
|---|---|---|---|---|---|
| Mean | 48.0 ± 13.18 | 51.0 ± 12.29 | 50.2 ± 13.74 | 49.3 ± 12.59 | 49.6 ± 12.96 |
| Sex: Female, Male(Participants) | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID | Total |
|---|---|---|---|---|---|
| Female | 40 | 43 | 43 | 43 | 169 |
| Male | 65 | 64 | 64 | 64 | 257 |
| Race (NIH/OMB)(Participants) | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 0 | 1 | 4 |
| Asian | 1 | 3 | 2 | 1 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 0 | 1 |
| Black or African American | 6 | 4 | 11 | 5 | 26 |
| White | 97 | 96 | 92 | 97 | 382 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 2 | 3 | 6 |
| Region of Enrollment(participants) | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID | Total |
|---|---|---|---|---|---|
| United States | 105 | 107 | 107 | 107 | 426 |
| Psoriasis Area and Severity Index (PASI)(units on a scale) | PPC-06 400 mg QD | PPC-06 400 mg BID | PPC-06 600 mg BID | Placebo BID | Total |
|---|---|---|---|---|---|
| Mean | 18.41 ± 6.377 | 18.56 ± 8.004 | 18.00 ± 6.680 | 17.26 ± 6.169 | 18.05 ± 6.842 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dr. Reddy's Laboratories Limited →