E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
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 |
The primary objectives are to compare the efficacy of ABT-122 versus placebo in subjects on background methotrexate (MTX) as assessed by ACR20 at Week 12 and to assess the safety and tolerability of ABT-122 in subjects with the active psoriatic arthritis (PsA). |
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E.2.2 | Secondary objectives of the trial |
● To compare the efficacy of ABT-122 versus adalimumab as assessed by ACR20 at Week 12
● To assess additional efficacy endpoints of ABT-122 as measured by:
- ACR50/70 response rates at Week 12
- Empirical cumulative distribution function of ACRn at Week 12
- Change from baseline in the DAS28[hsCRP] and PASDAS at Week 12
- Change from baseline in the Psoriasis Target Lesion Scores at Week 12
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adult male or female, 18 years of age or older.
2. PsA diagnosis of at least 3 months duration prior to the date of first Screening with CASPAR confirmed diagnosis at Screening.
3. Have active psoriasis defined by at least 1 psoriasis lesion ≥ 2 cm diameter in areas other than the axilla or groin.
4. Have active arthritis defined by minimum disease activity criteria:
• ≥ 3 swollen joints (based on 66 joint counts) at Screening.
• ≥ 3 tender joints (based on 68 joint counts) at Screening.
5. On a stable dose of MTX defined as:
• Oral or parenteral treatment ≥ 3 months,
• On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline
• Stable MTX dose of ≥ 10 mg/week and < the upper limit of the applicable approved local label.
• Subject can also be on stable doses of NSAIDs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate. |
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E.4 | Principal exclusion criteria |
1. Prior exposure to any TNF inhibitors including:
- Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or for safety concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior to the Baseline visit.
- Subjects on prior adalimumab may not be enrolled in the study.
- Prior exposure to other non-TNF inhibitor biological DMARDs will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the Baseline visit.
2. Current treatment with traditional oral DMARDs, including csDMARDs, (except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5 half-lives of a drug apart from MTX prior to the Baseline visit.
• Subject may have prior exposure to JAK inhibitors or to PDE4 inhibitors as long as they have been off therapy for at least 5 half-lives.
3. Stable prescribed dose of oral prednisone or prednisone equivalent ≥ 10 mg/day within 30 days of the Baseline visit.
4. Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.
5. Laboratory values of the following at the Screening visit:
• Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females,
• Absolute neutrophil count (ANC) < 1500/mm3 (or < 1200 cells/µL for subjects of African descent who are black),
• AST or ALT > 1.5 × the upper limit of normal (ULN) or bilirubin ≥ 3 mg/dL,
• Serum creatinine > 1.5 × the ULN,
• Platelets < 100,000 cells/(mm3) (109/L),
• Clinically significant abnormal screening laboratory results as evaluated by the Investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
ACR20 response rate at Week 12 with a primary comparison between ABT-122 versus placebo. |
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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) |
• Comparison of efficacy of ABT-122 versus adalimumab as assessed by ACR20 at Week 12
• Additional efficacy endpoints of ABT-122 as measured by:
o ACR50/70 response rates at Week 12
o Empirical cumulative distribution function of ACRn at Week 12
o Change from baseline in the DAS28[hsCRP] and PASDAS at Week 12
o Change from baseline in the Target Lesion Score at Week 12
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 70 |
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 |
Australia |
Bulgaria |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
Latvia |
New Zealand |
Poland |
Romania |
Spain |
United States |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 | 0 |