Phase 2
Completed N=132
Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT05268016 ↗Enrolled (actual)
132
Serious AEs
1.5%
Results posted
Jun 2024
Primary outcomePrimary: 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 — 58.3; 32.0; 61.5; 52.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
58.3; 32.0; 61.5; 52.0; 14.8 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over the 16-week Treatment Period and the 4-week Follow-up Period |
16; 17; 23; 24; 16 | — |
| SECONDARY Number of Participants With Serious TEAEs Over the 16-week Treatment Period and the 4-week Follow-up Period |
0; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period |
7; 11; 8; 15; 11; 9 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Physical Examination |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests |
0; 0; 0; 0; 0 | — |
| SECONDARY Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16 |
-22.87; -15.39; -24.47; -26.93; -12.01; -42.41 | — |
| SECONDARY Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16 |
12.5; 8.0; 7.7; 20.0; 7.4; 29.2 | — |
| SECONDARY Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16 |
4.2; 0; 0; 4.0; 0; 12.5 | — |
| SECONDARY Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to PASI-50 |
33.5; 57.0; 28.0; 29.0; 113.0 | — |
| SECONDARY Time to PASI-75 |
58.0; NA; 56.0; 57.0; NA | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 8.3 | — |
| SECONDARY Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16 |
-1.6; -2.1; -3.6; -3.5; -0.8; -5.6 | — |
| SECONDARY Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16 |
-1.7; -1.5; -2.7; -2.3; -1.2; -3.3 | — |
| SECONDARY Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16 |
-2.2; -2.4; -5.0; -3.3; -4.1; -5.1 | — |
| SECONDARY 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 |
22.7; 26.1; 65.2; 36.4; 44.4; 52.4 | — |
| SECONDARY Trough Serum Concentration (Ctrough) of ME3183 |
13998.33; 11491.05; 28559.81; 21229.09; 17973.10; 16522.41 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female, ages 18 to 75 years
- Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05268016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.