Plaque PsoriasisPhase 2NCT05268016
Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing ME3183 in people with Plaque Psoriasis, run by Meiji Pharma USA Inc. at 27 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- ME3183
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 24 Mar 2022to 31 May 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female, ages 18 to 75 years
- Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States14 sites
Studies in Dermatology, LLC
Cypress, Texas, 77433
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210
Qualmedica Research, LLC
Evansville, Indiana, 47715
Center for Clinical Studies LTD, LLP
Houston, Texas, 77004
Shondra L. Smith, MD Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, 70605
University of Southern California
Los Angeles, California, 90033
International Dermatology Research, INC
Miami, Florida, 33144
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Owensboro Dermatology Associates
Owensboro, Kentucky, 42303
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Premier Clinical Research
Spokane, Washington, 99202
Canada13 sites
SKiN Health
Cobourg, Ontario, K9A 0Z4
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta, T5J 3S9
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3A 1W8
Dermatrials Research Inc.
Hamilton, Ontario, L8N 1Y2
DermEffects
London, Ontario, N6H 5L5
Lynderm Research Inc.
Markham, Ontario, L3P 1X3
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Dr. David Gratton Dermatologue Inc.
Montreal, Quebec, H3H 1V4
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1
Toronto Research Centre
Toronto, Ontario, M3H 5Y8
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Efficacy and Safety of ME3183 Administered Orally in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to assess the efficacy and safety of ME3183 administered orally for moderate to severe plaque psoriasis in adults.
- Conditions
- Plaque Psoriasis
- Being tested
- ME3183, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME3183Drug
ME3183 capsule
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| ME3183 Dose 1, BID | Experimental | Specified dose of ME3183 capsule for 16 weeks Receives: Drug: ME3183 |
| ME3183 Dose 2, QD | Experimental | Specified dose of ME3183 capsule for 16 weeks Receives: Drug: ME3183 |
| ME3183 Dose 3, BID | Experimental | Specified dose of ME3183 capsule for 16 weeks Receives: Drug: ME3183 |
| ME3183 Dose 4, QD | Experimental | Specified dose of ME3183 capsule for 16 weeks Receives: Drug: ME3183 |
| Placebo | Placebo comparator | Placebo capsule of ME3183 for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Week 16
Secondary outcomes (19)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over the 16-week Treatment Period and the 4-week Follow-up Period
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.
Measured: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With Serious TEAEs Over the 16-week Treatment Period and the 4-week Follow-up Period
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.
Measured: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period
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.
Measured: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With Clinically Significant Abnormalities in Physical Examination
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.
Measured: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
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.
Measured: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests
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.
Measured: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Percent Change From Baseline in PASI Score at All Visits From Week 1 to 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 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.
Measured: Baseline, Week 1, 2, 4, 8, 12 and 16
Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to 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 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.
Measured: Baseline, Week 1, 2, 4, 8, 12 and 16
Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to 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 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.
Measured: Baseline, Week 1, 2, 4, 8, 12 and 16
Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to 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 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.
Measured: Baseline, Week 1, 2, 4, 8, 12 and 16
Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to 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 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.
Measured: Baseline, 1, 2, 4, 8, 12 and 16
Time to PASI-50
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.
Measured: Baseline to Week 16
Time to PASI-75
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.
Measured: Baseline to Week 16
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
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.
- = Almost clear: Normal to pink coloration of lesions; no thickening; no to minimal focal scaling.
- = 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.
Measured: Baseline, Week 1, 2, 4, 8, 12 and 16
Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 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.
Measured: Baseline, Week 1, 2, 4, 8, 12 and 16
Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 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.
Measured: Baseline, Week 1, 2, 4, 8, 12 and 16
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 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.
Measured: Baseline, Week 1, 2, 4, 8, 12 and 16
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
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.
Measured: Baseline, Week 1, 2, 4, 8, 12 and 16
Trough Serum Concentration (Ctrough) of ME3183
Ctrough of study drug was determined from the plasma samples using a validated analytical method.
Measured: Pre-dose at Week 1, 4, 8 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start24 Mar 2022
- Primary completion31 May 2023
- Study completion31 May 2023
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 Plaque 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Pharma USA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268016
- Sponsor's protocol ID
- ME3183-3
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2022
- Last updated
- 27 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Efficacy and Safety of ME3183 Administered Orally in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05268016
- Acronym / sponsor ID
- ME3183-3
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Meiji Pharma USA Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Posted 27 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of ME3183 administered orally for moderate to severe plaque psoriasis in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ME3183 Dose 1, BID | Experimental | Drug: ME3183Specified dose of ME3183 capsule for 16 weeks |
| ME3183 Dose 2, QD | Experimental | Drug: ME3183Specified dose of ME3183 capsule for 16 weeks |
| ME3183 Dose 3, BID | Experimental | Drug: ME3183Specified dose of ME3183 capsule for 16 weeks |
| ME3183 Dose 4, QD | Experimental | Drug: ME3183Specified dose of ME3183 capsule for 16 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule of ME3183 for 16 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female, ages 18 to 75 years
- Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| ME3183ME3183 capsule | Drug | ME3183 Dose 1, BID, ME3183 Dose 2, QD, ME3183 Dose 3, BID, ME3183 Dose 4, QD |
| PlaceboPlacebo capsule | Drug | Placebo |
Primary outcome
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
Time frame: 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.
19 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over the 16-week Treatment Period and the 4-week Follow-up Period
Time frame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With Serious TEAEs Over the 16-week Treatment Period and the 4-week Follow-up Period
Time frame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period
Time frame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With Clinically Significant Abnormalities in Physical Examination
Time frame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests
Time frame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16
Time frame: Baseline, Week 1, 2, 4, 8, 12 and 16
Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16
Time frame: Baseline, Week 1, 2, 4, 8, 12 and 16
Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16
Time frame: Baseline, Week 1, 2, 4, 8, 12 and 16
Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16
Time frame: Baseline, Week 1, 2, 4, 8, 12 and 16
Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16
Time frame: Baseline, 1, 2, 4, 8, 12 and 16
Time to PASI-50
Time frame: Baseline to Week 16
Time to PASI-75
Time frame: Baseline to Week 16
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
Time frame: Baseline, Week 1, 2, 4, 8, 12 and 16
Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16
Time frame: Baseline, Week 1, 2, 4, 8, 12 and 16
Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16
Time frame: Baseline, Week 1, 2, 4, 8, 12 and 16
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16
Time frame: Baseline, Week 1, 2, 4, 8, 12 and 16
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
Time frame: Baseline, Week 1, 2, 4, 8, 12 and 16
Trough Serum Concentration (Ctrough) of ME3183
Time frame: Pre-dose at Week 1, 4, 8 and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ME3183 in people with Plaque Psoriasis, run by Meiji Pharma USA Inc. at 27 sites in 2 countries.
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 2 inclusion and 14 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 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada. 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 27 Jun 2024). 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?
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 (time frame: Week 16). 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 27 Jun 2024.