Table of Contents
- Clinical trial overview
- Hidradenitis suppurativa study
- Rheumatoid arthritis study
- Psoriatic arthritis study
- Ulcerative colitis study
- Crohn’s disease study
- Main endpoints and what they mean
- Who may be included
Clinical trial overview
The source data shows five interventional trials studying Lutikizumab in inflammatory diseases.[1][1][1][1][1] These studies are all listed as Authorised, which means they have been approved to proceed.[1][1][1][1][1] The trials are mainly in adults, and one study also includes adolescents 12 years of age and older.[1] The conditions studied are hidradenitis suppurativa, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.[1][1][1][1][1]
Hidradenitis suppurativa study
This Phase 3 trial studies Lutikizumab in adults and adolescents with hidradenitis suppurativa, a painful skin disease that can cause lumps, abscesses, and draining tunnels.[1] The study compares Lutikizumab with placebo, which is a look-alike treatment without the active study drug.[1] It includes 1,305 participants and is designed to assess whether Lutikizumab improves the signs and symptoms of moderate to severe disease in people 12 years of age and older.[1]
The main endpoint is HiSCR 75 at Week 16, which means at least a 75% drop in total abscess and inflammatory nodule count, with no increase in abscesses or draining fistulas compared with the start of the study.[1] This endpoint helps show whether the skin disease is getting much better in a meaningful way.[1]
Rheumatoid arthritis study
This Phase 2 study looks at adults with moderately to severely active rheumatoid arthritis.[1] The trial evaluates the safety and efficacy of monotherapy and/or combination therapy, which means Lutikizumab may be studied alone or with another targeted therapy in the study plan.[1] The enrollment is 204 participants.[1]
The main outcome is the percentage of participants with an ACR50 response at Week 12.[1] ACR50 is a standard research measure that means a 50% improvement in rheumatoid arthritis signs and symptoms.[1]
Psoriatic arthritis study
This Phase 2 multicenter, randomized, platform study includes adults with active psoriatic arthritis.[1] Randomized means participants are assigned by chance to different study groups, and multicenter means the study is carried out at more than one site.[1] The trial includes 120 participants and studies Lutikizumab as monotherapy and in combination therapy, compared with another targeted therapy listed as ABBV-066.[1]
The study aims to evaluate both efficacy and safety, including tolerability, which means how well people can take the treatment without major problems in the study setting.[1] The primary endpoint is the percentage of participants with an ACR50 response at Week 16.[1]
Ulcerative colitis study
This Phase 2 trial studies adult participants with active ulcerative colitis, a disease that causes inflammation and sores in the large intestine.[1] The study compares Lutikizumab with adalimumab, another treatment named in the source data, and includes both intravenous infusion and subcutaneous injection forms in the study plan.[1] The enrollment is 207 participants.[1]
The main endpoint is the percentage of participants who achieve endoscopic improvement at Week 12.[1] Endoscopic improvement means the bowel looks better during a camera test called endoscopy, which helps researchers see whether inflammation is improving inside the intestine.[1]
Crohn’s disease study
This Phase 2 study includes adult participants with moderate to severe Crohn’s disease.[1] The trial is large, with 1,072 participants, and it evaluates several targeted therapies, including Lutikizumab.[1] The objective is to assess safety, efficacy, and the mechanistic profile of the studied therapies, which means the researchers also want to understand how the treatments behave in the body in the context of the study.[1]
The primary endpoint is endoscopic remission at Week 12.[1] Endoscopic remission means the bowel looks much improved during endoscopy, with little or no visible inflammation.[1]
Main endpoints and what they mean
Across these trials, the main outcomes focus on how well the disease improves after treatment.[1][1][1][1][1] In skin and joint disease, the studies use measures like HiSCR 75 and ACR50 to track symptom improvement.[1][1][1] In bowel disease, the studies use endoscopic improvement and endoscopic remission to see whether inflammation inside the intestine is getting better.[1][1]
These endpoints matter because they give a clear, standard way to compare treatment groups in a clinical trial.[1][1][1][1][1] They help researchers judge whether Lutikizumab may reduce symptoms and disease activity better than the comparison treatment.[1][1][1][1][1]
Who may be included
Based on the source data, the studies are mainly for adult participants.[1][1][1][1] The hidradenitis suppurativa trial also includes adolescents aged 12 years and older.[1] People in the trials have moderate to severe or active disease, depending on the condition being studied.[1][1][1][1][1]
The trial data do not provide full inclusion or exclusion rules, so the exact participation criteria are not listed here.[1][1][1][1][1] What is clear is that the studies focus on people with active inflammatory disease who match the condition and age group for each trial.[1][1][1][1][1]
