A study comparing the efficacy and safety of BAT2506 and Simponi® in participants with active psoriatic arthritis

INTERVENTION: Product Name: BAT2506, proposed golimumab biosimilar Product Code: BAT2506 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: GOLIMUMAB CAS Number: 476181‐74‐5 Current Sponsor code: BAT2506 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ Trade Name: Simponi® Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: GOLIMUMAB CAS Number: 476181‐74‐5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ CONDITION: Psoriatic arthritis (PsA) ; MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: The primary objective is to demonstrate the equivalence of BAT2506 and Simponi® on the efficacy parameter, American College of Rheumatology (ACR) 20 response, in participants with active PsA. Primary end point(s): Percentage of participants achieving ACR 20 response at Week 8 Secondary Objective: ‐ To compare the efficacy of BAT2506 with Simponi® on additional efficacy parameters in participants with active PsA;; ‐ To compare the PK and PD parameter of BAT2506 with Simponi® in participants with active PsA;; ‐ To compare the safety of BAT2506 with Simponi®;; ‐ To compare the immunogenicity and of BAT2506 with Simponi®; ‐ To assess safety and immunogenicity following transition from Simponi® to BAT2506; Timepoint(s) of evaluation of this end point: Week 8 SECONDARY OUTCOME: Secondary end point(s): ‐ Percentage of participants achieving ACR 20/50/70 over time; ‐ Percentage of participants achieving PASI 75/PASI 90/PASI 100 response over time (in a subset of participants with at least 3% body surface area psoriasis involvement at baseline); ‐ Change from baseline in DAS28‐CRP over time; ‐ Percentage of participants achieving DAS28 CRP response (good or moderate response) over time; ‐ Change from baseline in HAQ DI over time; ‐ Change from baseline in NAPSI over time; ‐ Change from baseline in all individual ACR core components: swollen joint count, tender joint count, Patient's assessment of Arthritis Pain (VAS), Participant's Global Assessment of Disease Activity (VAS), Physician's Global Assessment of Disease Activity (VAS), HAQ‐DI, and CRP over time; ‐ Change from baseline in PASI over time.; ‐ PK parameters; truncated AUC after first administration until second administration (AUC0 t), AUC over dosage interval at steady state (AUC0 t), maximum concentration at steady state (Cmax) and trough concentration before next dosing of study drug at steady state (Ctrough), determined using a population PK modeling approach.; ‐ Impact of CRP on efficacy and safety, if applicable.; ‐ AEs, clinical laboratory values, vital signs, ECG, injection site reactions.; ‐ ADAs (including an estimate of titer), neutralizing antibodies, and assessment of the impact of immunogenicity on PK, efficacy, and safety, if applicable.; ‐ AE, ADAs, neutralizing antibodies, and assessment of the impact of immunogenicity on PK, efficacy, and safety, if applicable. Timepoint(s) of evaluation of this end point: Please refer to section E.5.2 INCLUSION CRITERIA: •Receipt of a signed/dated informed consent. •Male or female, aged from 18 to 80 years at Screening. •PsA for at least 6 months prior to the first IMP dose and compliance with CASPAR at Screening. •Active PsA defined by the presence of =3 of 68 tender joint counts and =3 of 66 swollen joint counts at Screening and Randomization. •Active PsA at Screening despite previous DMARD or NSAID therapy. DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks (or have intolerance to or contraindication to NSAID therapy). •At least 1 active psoriatic lesion with a qualifying lesion of at least 2 cm in diameter at Screening and Randomization. •Subject is negative for rheumatoid factor and ACCP antibodies at Screening. •Female subjects must be: Postmenopausal OR Permanently sterilized OR If of childbearing potential, must be willing to use a hig