E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active Psoriatic Arthritis |
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E.1.1.1 | Medical condition in easily understood language |
Active Psoriatic Arthritis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 compare the efficacy of deucravacitinib to placebo in the treatment of participants with active PsA |
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E.2.2 | Secondary objectives of the trial |
To compare the efficacy of deucravacitinib to placebo at Week 16:
- as assessed by DAS28-CRP
- as assessed by HAQ-DI
- as assessed by PASI 75 response
- as assessed by SF-36 PCS score
- in enthesitis resolution
- in MDA response
- in FACIT-Fatigue
- in dactylitis resolution
- as assessed by structural damage
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participant has been diagnosed to have PsA (by any criteria) of at least 3 months duration at Screening.
- Participant meets the CASPAR criteria at Screening.
- Participant has active plaque psoriatic skin lesion(s) or documented medical history of plaque PsO at Screening.
- Participant has active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints (66/68 joint counts) at Screening and Day 1.
- Participant has ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening period that is confirmed by central reading.
- Participant has hsCRP ≥ 3 mg/L at Screening.
- Participant has had documented inadequate response, loss of response or intolerance to at least 1 of the following:
• A csDMARD at maximally tolerated dose, and/or apremilast, after a minimum of 12 weeks duration of therapy given for the treatment of PsA
• An NSAID after a minimum of 4 weeks duration of therapy given for the treatment of PsA, or participant has intolerance to those treatments in the opinion of the investigator
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E.4 | Principal exclusion criteria |
- Participant has non-plaque PsO (ie, guttate, pustular, erythrodermic or drug-induced PsO) at Screening or Day 1.
- Participant has any other autoimmune condition such as, systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
- Participant has prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
- Participant has active (ie, currently symptomatic) fibromyalgia whose symptoms or therapy will significantly impact the assessment of PsA disease manifestations and activity in the opinion of the investigator.
- Participant has received an approved or investigational biologic therapy for the treatment of PsA or PsO.
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants meeting ACR 20 response |
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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) |
1- Change from baseline in DAS28-CRP score
1- Change from baseline in HAQ-DI score
1- Proportion of participants meeting PASI 75 response
1- Change from baseline in the SF-36 PCS
1- Proportion of participants meeting enthesitis resolution
1- Proportion of participants meeting achievement of MDA
1- Change from baseline in FACIT-Fatigue
1- Proportion of participants meeting dactylitis resolution
1- Change from baseline in PsA-modified SvdH score
Additional Secondary Endpoints
2- Proportion of participants meeting ACR 20, ACR 50, and ACR 70 response
2- Change from baseline in HAQ-DI score
2- Proportion of participants who achieve a clinically meaningful improvement in HAQ-DI score
2- Proportion of participants with achievement of PASI 75/90/100 response
2- Change from baseline in the SF-36 PCS score
2- Proportion of participants meeting enthesitis resolution
2- Proportion of participants meeting achievement of MDA
2- Change from baseline in SF-36 Score MCS
2- Change from baseline in FACIT-Fatigue
2- Proportion of participants meeting dactylitis resolution
2- Change from baseline in PsAID 12
2- Change from baseline in DAPSA score
2- Proportion of participants meeting achievement of PGA-F of 0/1
2- Change from baseline in DAS28-CRP score
2- Change from baseline in PASDAS
2- Change from baseline in mCPDAI score
2- Proportion of participants achieving PsARC response
2- Proportion of participants meeting achievement of improvement from baseline in BASDAI score
1- Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0, ≤ 0.5, and ≤ SDC
1- Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0, ≤ 0.5, and ≤ SDC
1- Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ 0, ≤ 0.5, and ≤ SDC
1- Change in PsA-modified SvdH erosion score from baseline
1- Change in PsA-modified SvdH JSN score
2- Change from baseline in domain scales scores, PCS, and MCS of SF-36
2- Change from baseline in the subcomponents of the WPAI questionnaire
2- Change from baseline in the 5-level EQ-5D utility scores and its subcomponents
2- Change from baseline in PROMIS sleep disturbance (short form)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1- At Week 16
2- At Each Time Point up to Week 16 |
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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 | Yes |
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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 67 |
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 |
Brazil |
Chile |
China |
Colombia |
Mexico |
Russian Federation |
Taiwan |
Finland |
France |
Germany |
Hungary |
Ireland |
Italy |
Poland |
Romania |
Spain |
United Kingdom |
Czechia |
Argentina |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 16 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 4 |