Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT05268016
- Lead Sponsor
- Meiji Pharma USA Inc.
- Brief Summary
The purpose of this study is to assess the efficacy and safety of ME3183 administered orally for moderate to severe plaque psoriasis in adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- Male and female, ages 18 to 75 years
- Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.
- Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
- Active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening.
- Hepatitis B surface antigen positive at Screening.
- History of HIV or Positive for the HIV antibodies at Screening.
- History of allergy to any component of the study treatment.
- Active tuberculosis (TB) or a history of incompletely treated TB.
- Active infection (bacteria, viral, fungal, etc.) requiring treatment with systemic antibiotics within 4 weeks of Screening.
- Malignancy or history of malignancy except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence.
- Pregnant or breast feeding
- Received ustekinumab, secukinumab, brodalumab, ixekizumab, guselkumab, risankizumab, tildrakizumab, or briakinumab within 24 weeks of first administration of study treatment.
- Received TNF-α inhibitor(s)/blocker(s) within 8 weeks of first administration of study treatment.
- Received rituximab within 24 weeks of first administration of study treatment.
- Received phototherapy or any systemic medications/treatments within 4 weeks of the first administration of study treatment.
Other protocol defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ME3183 Dose 4, QD ME3183 Specified dose of ME3183 capsule for 16 weeks ME3183 Dose 1, BID ME3183 Specified dose of ME3183 capsule for 16 weeks ME3183 Dose 2, QD ME3183 Specified dose of ME3183 capsule for 16 weeks Placebo Placebo Placebo capsule of ME3183 for 16 weeks ME3183 Dose 3, BID ME3183 Specified dose of ME3183 capsule for 16 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Greater Than or Equal to (>=) 75% Reduction From Baseline in Psoriasis Area Severity Index (PASI) Score (PASI-75) at Week 16 Week 16 The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score.
The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over the 16-week Treatment Period and the 4-week Follow-up Period Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20) An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening, worsens during the study, regardless of the suspected cause of the event. A Treatment-Emergent Adverse Event (TEAE) is an AE that occurred during the study after the first dose of study drug or that was present prior to dosing and exacerbates after the first dose of study drug.
Number of Participants With Clinically Significant Abnormalities in Physical Examination Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20) Physical Examination included height and body mass index. Any change in Physical examination abnormalities that were deemed clinically significant by the investigator were recorded as TEAEs.
Number of Participants With Clinically Significant Abnormalities in Vital Signs Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20) Vital signs parameters included blood pressure, heart rate, respiratory rate, body temperature, and body weight. Any change in vital sign abnormalities that were deemed clinically significant by the investigator were recorded as TEAEs.
Trough Serum Concentration (Ctrough) of ME3183 Pre-dose at Week 1, 4, 8 and 16 Ctrough of study drug was determined from the plasma samples using a validated analytical method.
Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20) An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening, worsens during the study, regardless of the suspected cause of the event. AEs were classified by severity as follows:
MILD: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities.
MODERATE: An event that is sufficiently discomforting to interfere with normal everyday activities.
SEVERE: An event that prevents normal everyday activities.Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16 Baseline, Week 1, 2, 4, 8, 12 and 16 The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). Total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by constant. Scores for each anatomic region are combined to yield final PASI score (0 to 72). Higher scores= greater disease severity. Negative change from baseline indicates an improvement of disease symptoms. Percent reduction= (PASI score at Baseline - score at a follow-up visit) / PASI score at Baseline \* 100.
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16 Baseline, Week 1, 2, 4, 8, 12 and 16 DLQI is a 10-item questionnaire that measures the impact of skin disease on a participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI a total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on the quality of life of participants. Negative change from baseline indicates improvement.
Percentage of Participants With at Least a 5-point Reduction From Baseline in the DLQI Score at All Visits From Week 1 to Week 16 Baseline, Week 1, 2, 4, 8, 12 and 16 DLQI is a 10-item questionnaire that measures the impact of skin disease on a participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI a total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on the quality of life of participants.
Number of Participants With Serious TEAEs Over the 16-week Treatment Period and the 4-week Follow-up Period Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20) An SAE is any untoward medical occurrence, in the view of either the investigator or Sponsor, that:
* results in death,
* is life-threatening,
* results in inpatient hospitalization or prolongation of existing hospitalization,
* results in persistent or significant disability/incapacity, and/or
* is a congenital anomaly/birth defect. Other important medical events that may not be immediately life-threatening or result in death or hospitalization, based upon appropriate medical judgement, are considered SAEs if they are thought to jeopardize the subject and/or require medical or surgical intervention to prevent one of the outcomes defining an SAE.Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16 Baseline, Week 1, 2, 4, 8, 12 and 16 The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score.
The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16 Baseline, Week 1, 2, 4, 8, 12 and 16 The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score.
The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.Time to PASI-50 Baseline to Week 16 Time to the first response of PASI-50 was defined as the number of days from the first dose of the study drug to the first response.
Time to PASI-75 Baseline to Week 16 Time to the first response of PASI-75 was defined as the number of days from the first dose of the study drug to the first response.
Percentage of Participants Achieving a Static Physicians Global Assessment (sPGA) Score of "0" ("Clear") or "1" ("Almost Clear") Combined With 2-point Reduction on the 5-point sPGA Scale at All Visits From Week 1 to Week 16 Baseline, Week 1, 2, 4, 8, 12 and 16 The Percentage of participants who achieved the static Physician's Global Assessment (sPGA) score of 'clear' or 'almost clear' (sPGA score 0 or 1) combined with 2-point reduction on the 5-point sPGA scale were reported. The investigator rated the severity of participant's psoriasis on the 5-point scale ranging from 0 (clear) to 4 (severe).
0 = Clear: No signs of psoriasis. Post-inflammatory hyperpigmentation may be present.
1. = Almost clear: Normal to pink coloration of lesions; no thickening; no to minimal focal scaling.
2. = Mild: Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling.
3= Moderate: Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling.
4 = Severe: Bright to deep dark red coloration; severe thickening with hard edges; severe/coarse scaling covering almost all or all lesions.
Missing values are imputed as non-responders via NRI.Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16 Baseline, Week 1, 2, 4, 8, 12 and 16 BSA is a measurement of the affected skin area. The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16 Baseline, Week 1, 2, 4, 8, 12 and 16 The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." The overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. Negative change from baseline indicates improvement.
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20) Clinical laboratory testing included electrocardiogram (ECG), hematology, coagulation, blood chemistry, and urinalysis. Any change in clinical laboratory abnormalities that were deemed clinically significant by the investigator were recorded as TEAEs.
Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16 Baseline, Week 1, 2, 4, 8, 12 and 16 The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score.
The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16 Baseline, 1, 2, 4, 8, 12 and 16 The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score.
The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (27)
SKiN Health
🇨🇦Cobourg, Ontario, Canada
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
Toronto Research Centre
🇨🇦Toronto, Ontario, Canada
Dermatology Ottawa Research Centre
🇨🇦Ottawa, Ontario, Canada
International Dermatology Research, INC
🇺🇸Miami, Florida, United States
Qualmedica Research, LLC
🇺🇸Evansville, Indiana, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
Colorado Medical Research Center, Inc.
🇺🇸Denver, Colorado, United States
Northwest Arkansas Clinical Trials Center
🇺🇸Rogers, Arkansas, United States
Shondra L. Smith, MD Dermatology & Advanced Aesthetics
🇺🇸Lake Charles, Louisiana, United States
Owensboro Dermatology Associates
🇺🇸Owensboro, Kentucky, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Center for Clinical Studies LTD, LLP
🇺🇸Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Studies in Dermatology, LLC
🇺🇸Cypress, Texas, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Laser Rejuvenation Clinics Edmonton D.T. Inc
🇨🇦Edmonton, Alberta, Canada
Dermatrials Research Inc.
🇨🇦Hamilton, Ontario, Canada
DermEffects
🇨🇦London, Ontario, Canada
Sudbury Skin Clinique
🇨🇦Sudbury, Ontario, Canada
K. Papp Clinical Research
🇨🇦Waterloo, Ontario, Canada
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
Dr. David Gratton Dermatologue Inc.
🇨🇦Montreal, Quebec, Canada
DermEdge Research
🇨🇦Mississauga, Ontario, Canada
Skinsense Medical Research
🇨🇦Saskatoon, Saskatchewan, Canada