Table of Contents

• Overview of the research program
• Inflammatory bowel disease studies
• Psoriatic arthritis studies
• Psoriasis studies
• Pediatric and long-term safety studies
• Special study designs and extra outcomes
• Main endpoints used in the trials

Overview of the research program

The trial data show a broad research program for Guselkumab across bowel, skin, and joint diseases.^[1] Most studies are Phase 3, which usually means larger studies that test how well a treatment works and continue safety checks.^[1] There are also Phase 2 and Phase 4 studies, so the research includes both earlier testing and later real-world style evaluation.^[1]

Inflammatory bowel disease studies

Several trials study Crohn’s disease and ulcerative colitis, which are long-term diseases that cause inflammation in the bowel.^[1] These studies include adults with moderately to severely active disease, as well as pediatric participants in separate studies.^[1]

In Crohn’s disease, the trials look at clinical remission, endoscopic response, and in one study, transmural healing, which means healing through the full thickness of the bowel wall.^[1] One Phase 4 Crohn’s study compares a Phase 2 part and a Phase 3 part, with outcomes that include change in disease activity and combined clinical and endoscopic endpoints.^[1]

In ulcerative colitis, the studies test induction therapy, maintenance therapy, and long-term safety in both adults and children.^[1] The main outcomes include clinical remission, clinical response, and endoscopic response at set time points such as Week 12, Week 48, or Week 56.^[1]

One Crohn’s study focuses on fistulizing perianal disease, which means Crohn’s disease with abnormal tunnels near the anus.^[1] Its main goal is combined fistula remission at Week 24.^[1] Another study looks at pouchitis, a condition that causes inflammation in a surgically created pouch, and tests Guselkumab alone or with a dietary intervention.^[1]

Psoriatic arthritis studies

Multiple trials study psoriatic arthritis, an inflammatory joint disease linked to psoriasis.^[1] The studies include people with active psoriatic arthritis, people with prior anti-TNF treatment failure or intolerance, and people with axial disease, which affects the spine and lower back.^[1]

One Phase 3 study examines whether Guselkumab can help people with active psoriatic arthritis reach an ACR 20 response by Week 24, which means at least 20% improvement in arthritis signs and symptoms.^[1] Another study measures changes in BASDAI, a score used to track symptoms in axial disease, at Week 24.^[1]

Some arthritis studies are more specific. One open-label trial studies enthesitis, which is inflammation where tendons or ligaments attach to bone, and measures whether it resolves by Week 24.^[1] Another study looks at subclinical psoriatic arthritis, meaning early disease that may not yet be fully obvious, and tests whether symptoms and ultrasound signs improve by Week 24.^[1]

There is also a pediatric juvenile psoriatic arthritis study that evaluates both efficacy and pharmacokinetics, with ACR Pedi 30 response as one of the listed outcomes.^[1]

Psoriasis studies

The psoriasis trials study adults and children with plaque psoriasis, including moderate-to-severe disease.^[1] These studies compare Guselkumab with placebo, with other biologics, or with different treatment schedules.^[1]

One Phase 3b study asks whether people who respond very well can keep disease control with longer treatment intervals.^[1] Its main outcome is the proportion of participants who reach an absolute PASI score below 3 at Week 68.^[1] Another Phase 3 study in moderate-to-severe psoriasis tests whether proactive therapeutic drug monitoring, which means checking treatment levels to guide care, is not worse than standard care for sustained disease control over 18 months.^[1]

A small psoriasis study examines tissue-resident memory T-cells, which are immune cells that stay in the skin and may help drive disease memory.^[1] This study focuses on changes in these cells and nearby protein signals during Guselkumab treatment.^[1]

Pediatric psoriasis research also includes a trial in children aged 6 through under 18 years with chronic plaque psoriasis, where the main outcome is PASI 75 at Week 16.^[1]

Pediatric and long-term safety studies

Several trials are designed for pediatric participants with ulcerative colitis, Crohn’s disease, or juvenile psoriatic arthritis.^[1] These studies help researchers learn how Guselkumab performs in younger patients, including safety, effectiveness, and how the body processes the treatment.^[1]

One long-term extension study follows pediatric participants over time and is focused on long-term safety rather than a single primary endpoint.^[1] Another pediatric study in ulcerative colitis measures clinical remission at Week 56 in participants who first responded during induction therapy.^[1] Pediatric Crohn’s disease research also measures clinical remission and endoscopic response at Week 52.^[1]

Special study designs and extra outcomes

Some trials test Guselkumab in special ways, such as combination therapy, treatment tapering, or real-world care.^[1] For example, one Crohn’s and one ulcerative colitis study compare Guselkumab plus golimumab against each medicine alone.^[1] Another study in psoriatic arthritis asks how far immunosuppressive treatment can be tapered without symptoms coming back.^[1]

One Crohn’s trial compares immediate biologic treatment after surgery with endoscopy-driven treatment after recurrence.^[1] Another study in pouchitis compares Guselkumab alone with Guselkumab plus diet support to see whether symptoms improve more with the combined approach.^[1]

Main endpoints used in the trials

The most common endpoints are clinical remission, clinical response, and endoscopic response.^[1] In skin studies, researchers often use PASI-based measures, while in arthritis studies they use ACR 20, ACR Pedi 30, BASDAI, or scores for enthesitis and disease activity.^[1]

Some studies use imaging or tissue-based outcomes, such as MaRIA for bowel healing, ultrasound measures for enthesitis, and skin tissue markers for TRMs.^[1] Pediatric studies and combination studies may also include pharmacokinetics, which helps show how the treatment behaves in the body, and long-term safety follow-up.^[1]