E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate-to-Severe Plaque Psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the safety and tolerability of long-term use of BMS-986165 in subjects with moderate-to-severe plaque psoriasis |
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E.2.2 | Secondary objectives of the trial |
To characterize the maintenance of response to BMS-986165 in the treatment of subjects with moderateto- severe plaque psoriasis |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Vaccine substudy: USA, Canada and Poland part of country specific protocol amendment 01 dated 16 June 2022 Substudy title: A Prospective, Multicenter, Randomized, Parallel group, Placebo-controlled, Double blind, Phase 3b Substudy of IM011075 to Evaluate the Immune Response to and Safety of Pneumococcus and Tetanus Toxoid Vaccines in Subjects with moderate-to-Severe Plaque Psoriasis Receiving Deucravacitinib (BMS-986165) Primary objective: •To compare the proportion of subjects meeting serologic response criteria to tetanus toxoid antigen and pneumococcus serologic response at Week 4 (Day 36) in subjects on deucravacitinib versus those on placebo Secondary objectives: • To compare the proportion of subjects achieving seroprotection in tetanus toxoid–specific antibody titers in subjects on deucravacitinib versus those on placebo • To compare the proportion of subjects achieving seroconversion in tetanus toxoid–specific antibody titers in subjects on deucravacitinib versus those on placebo • To compare immune responses elicited by PPSV23 measured by OPA in subjects on deucravacitinib versus those on placebo • To determine the safety and tolerability of Pneumovax 23 and of Pneumovax 23 and Boostrix vaccines while on deucravacitinib |
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E.3 | Principal inclusion criteria |
1) Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis 2) Subjects must be willing to participate in IM011075 and must have the ability to sign the informed consent form (ICF). 3) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period (must have a negative urine pregnancy test 24 hours prior to the start of study drug. |
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E.4 | Principal exclusion criteria |
1) Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason 2) Prior permanent discontinuation of study treatment in the parent study 3) Findings Related to Possible TB Infection 4) Evidence of active TB |
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E.5 End points |
E.5.1 | Primary end point(s) |
Adverse events and serious adverse events |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
sPGA 0/1 response PASI 75 response
sPGA 0 response PASI 90 response PASI 100 response Change from baseline and percent change from baseline in BSA Change from baseline in PSSD total score Change from baseline in PSSD symptom score Change from baseline in PSSD sign score PSSD total score of 0 PSSD symptom score of 0 PSSD sign score of 0 Change from baseline in DLQI score DLQI 0/1 EQ-5D-3L Change from baseline in WLQ score ss-PGA 0/1 response PGA-F 0/1 response |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Please see schedule of events in the Protocol for timepoints. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 32 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 99 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
New Zealand |
Taiwan |
Australia |
Canada |
China |
Israel |
Japan |
Korea, Republic of |
Russian Federation |
United Kingdom |
United States |
Czechia |
Finland |
France |
Germany |
Hungary |
Poland |
Spain |
Sweden |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 33 |