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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

INDUCTION STUDY Primary Objectives:* To evaluate the efficacy of intravenous (IV) ustekinumab in inducing clinical remission in subjects with moderately to severely active UC.* To evaluate the safety of IV ustekinumab in subjects with moderately to…

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis.

1. Primary Objectives of the study: The primary objectives of this study are to evaluate the efficacy and safety of 2 SC dosing tiers of ustekinumab in the treatment of adolescent subjects * 12 to < 18 years of age with moderate to severe…

A prospective *proof of concept study* to evaluate the potential efficacy of ustekinumab in patients with moderate to severe hidradenitis suppurativa (acne ectopica)

Primary objective: 1. To evaluate the effect of ustekinumab in patients with moderate to severe hidradenitis suppurativa (Hurley II-III), measured by disease specific score systmes: Sartorius/HS-LASI and PGA 2. To evaluate possible changes in scores…

A prospective study to determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in patients with moderate to severe chronic plaque psoriasis.

To determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in patientswith moderate to severe chronic plaque psoriasis.

An exploratory trial to assess naturalistic safety and efficacy outcomes in patients trasitioned to ustekinumab from previous methotrexate therapy

Primary Objective: The primary objective of this exploratory trial is to evaluate the comparative safety through Week 12 of two treatment transition strategies in patients with inadequate response to methotrexate: discontinuation of methotrexate…

A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

The objective of this clinical research study is to evaluate the safety and effectiveness of brodalumab, compared with ustekinumab and placebo, for the treatment of moderate to severe plaque psoriasis.

A 52-week, multicenter, randomized, double-blind study of subcutaneous secukinumab to demonstrate efficacy as assessed by Psoriasis Area and Severity Index at 16 weeks of treatment compared to ustekinumab and to assess long-term safety, tolerability and efficacy in subjects with
moderate to severe plaque psoriasis (CAIN457A2317)

Primary: To demonstrate the superiority of secukinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16, compared to ustekinumab.Secondary: To demonstrate the superiority of secukinumab in…

Tight control dose reductions of biologics in psoriasis patients with low disease activity: a randomized pragmatic trial.

To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease: is dose reduction non-inferior to the current practice regarding clinical effectiveness? Secondary aims are: to investigate what influence…

Protocol I1F-MC-RHBS;A 52-Week Multicenter, Randomized, Blinded, Parallel Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis

The primary objectives of this study are to assess whether 80 mg ixekizumab every 2 weeks (Q2W) is:• noninferior to ustekinumab at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis as measured by proportion of patients…

Mechanism of action study of Ustekinumab treatment in psoriatic arthritis:
Impact on cellular and molecular pathways of synovial inflammation and tissue remodeling

ObjectivePlease describe:• the specific goal to be reached by the study• the hypothesis to be answered by the studyThe overall aim of the study is to determine which downstream cellular and molecular pathways involved in PsA pathogenesis are…

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

This study has been transitioned to CTIS with ID 2023-504736-18-00 check the CTIS register for the current data. Primary Objectives (Phase 2 and Phase 3):- To evaluate the clinical efficacy of guselkumab in participants with Crohn*s disease- To…

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn*s Disease

The objective of this trial is to show that Ustekinumab is superior to adalimumab as measured by clinical remission after one year of treatment in biologic naïve subjects with moderately-to-severely active CD who have previously failed or were…

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn*s Disease Patients Treated with Ustekinumab

A *treat to target* strategy has been advocated as an optimized management approach for various diseases, by which strictly defined treatment targets facilitate decision making in clinical practice. Key to the success of this treatment strategy is…

A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

This study has been transitioned to CTIS with ID 2023-507144-36-00 check the CTIS register for the current data. Primary:Evaluate PK and efficacy of ustekinumab and guselkumab in jPsA. Secondary:Evaluate safety of ustekinumab and guselkumab in…

A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn*s Disease who have failed anti-TNF therapy.

This study has been transitioned to CTIS with ID 2022-501645-70-00 check the CTIS register for the current data. Part 1:The objective is to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks for the treatment of adult…