Phase 3
N=443
MSB11022 in Moderate to Severe Chronic Plaque Psoriasis
Psoriasis · Plaque Type Psoriasis · Moderate to Severe Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02660580 ↗Enrolled (actual)
443
Serious AEs
3.9%
Results posted
Feb 2019
Primary outcome: Primary: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 — 89.7; 91.6 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MSB11022 (Drug); Humira® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 |
89.7; 91.6 | — |
| SECONDARY Percent Change From Baseline in PASI at Week 16 |
-90.6; -91.7 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 |
100.0; 100.0; 64.0; 66.0; 33.0; 37.2 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 |
100.0; 98.9; 100.0; 92.5; 88.3; 94.6 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 |
97.8; 100.0; 100.0; 90.9; 92.9; 93.1 | — |
| SECONDARY Percent Change From Baseline in PASI at Week 24 and 52 |
-92.9; -91.3; -94.2; -92.8; -93.9; -94.8 | — |
| SECONDARY Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 16 |
52; 51; 76; 59; 16; 20 | — |
| SECONDARY Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 |
69; 25; 25; 52; 24; 31 | — |
| SECONDARY Time to Achieve PASI 50 |
1.6; 1.6 | — |
| SECONDARY Time to Achieve PASI 75 |
2.5; 1.7 | — |
| SECONDARY Time to Achieve PASI 90 |
3.4; 2.6 | — |
| SECONDARY Time to Achieve PASI 100 |
7.2; 7.2; 8.9 | — |
| SECONDARY Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 |
52; 51; 76; 59; 16; 17 | — |
| SECONDARY Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 |
69; 25; 25; 52; 24; 31 | — |
| SECONDARY Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 |
74; 29; 34; 40; 13; 16 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 |
114; 117; 8; 6; 2; 3 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 |
142; 65; 63; 12; 3; 4 | — |
| SECONDARY Number of Participants With Clinically Meaningful Differences in Laboratory Values |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 |
205; 190; 6; 10; 201; 186 | — |
| SECONDARY Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 |
188; 89; 92; 186; 85; 88 | — |
| SECONDARY Number of Participants With Clinically Meaningful Differences in Vital Signs |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG) |
0; 1; 0; 1; 1 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) at Week 16 |
2.4; 2.5 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) at Week 24 and 52 |
2.5; 2.3; 2.3; 3.0; 2.1; 2.7 | — |
| SECONDARY European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16 |
0.9; 0.9 | — |
| SECONDARY European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 |
0.8; 0.9; 0.9; 0.9; 0.9; 0.8 | — |
| SECONDARY European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16 |
81.9; 83.1 | — |
| SECONDARY European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 |
83.2; 84.2; 84.3; 83.5; 85.1; 82.1 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16 |
0.3; 0.3 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 |
0.3; 0.2; 0.4; 0.3; 0.1; 0.5 | — |
| SECONDARY Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16 |
26.9; 24.6 | — |
| SECONDARY Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 |
29.7; 20.6; 24.9; 25.0; 14.7; 29.5 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16 |
186; 179; 70; 70 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 |
185; 89; 90; 170; 78; 85 | — |
| SECONDARY Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16 |
8.0; 8.0 | — |
| SECONDARY Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 |
16.0; 16.0; 16.0; 16.0; 16.0; 16.0 | — |
| SECONDARY Observed Serum Concentration at Week 16 |
6990; 6410 | — |
| SECONDARY Observed Serum Concentration at Week 24 and 52 |
6240; 5870; 6430; 6910; 5930; 6600 | — |
Summary
The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.
Eligibility Criteria
Inclusion Criteria
- Male or female participants greater than or equal to (>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index [PASI] score >=12, Physician Global Assessment [PGA] score >=3, and >=10% of body surface area affected at Screening and Baseline [Day 1 of Week 1]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque-type psoriasis despite topical therapy
- Participants must not have received more than 1 biologic therapy
- Other protocol-defined inclusion criteria could apply
Exclusion Criteria
- Participants was excluded if they have erythrodermic, pustular, guttate, or medication-induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis
- Participants must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP) administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration
- Participants was excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis [TB]); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex
- Other protocol-defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02660580). 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.