Table of Contents
- Trials at a glance
- Crohn’s disease studies
- Ulcerative colitis studies
- Other conditions studied
- Trial design and phases
- What the endpoints mean
- Who may join these studies
Trials at a glance
Tulisokibart is being studied in multiple interventional clinical trials, which means people receive a study treatment and researchers measure the results. The source data includes studies in Crohn’s disease, ulcerative colitis, radiographic axial spondyloarthritis, rheumatoid arthritis, hidradenitis suppurativa, systemic sclerosis associated with interstitial lung disease, and psoriatic arthritis.[1][2][3][4][5][6][7][8][9][10][11]
The trials range from small early studies to large later-stage studies, with enrollment from 16 to 1200 participants. The listed phases include Phase 2, Phase 3, and Phase 4, and several studies compare Tulisokibart with placebo.[1][2][3][4][5][6][7][8][9][10][11]
Crohn’s disease studies
Several trials focus on Crohn’s disease, a long-term inflammatory bowel disease that affects the digestive tract. One large Phase 3 study, NCT06430801, is authorised and plans to enroll 1200 people with Crohn’s disease.[1]
That Phase 3 study has two parts in the source data. It measures clinical remission, which means the disease is less active, and endoscopic response, which means improvement seen on a camera test inside the bowel.[1]
The main time points for this Crohn’s disease trial are Week 12 and Week 52. The study uses different remission measures for different regions, including the Crohn’s Disease Activity Index, also called CDAI, and a stool frequency and abdominal pain score.[1]
A smaller Phase 2 Crohn’s disease study, NCT05013905, is completed and enrolled 16 people. It looked at safety, tolerability, and endoscopic improvement at Week 12, using a measure called SES-CD, which is a score from endoscopy findings.[2]
Ulcerative colitis studies
Ulcerative colitis is another inflammatory bowel disease studied with Tulisokibart. The source data includes completed and authorised Phase 3 studies, plus one completed Phase 2 study, showing that this condition is a major focus of the research program.[6][7][8][9]
One Phase 3 study, NCT06052059, enrolled 802 participants and looked at clinical remission per modified Mayo score at Week 12. Another Phase 3 study, 2023-507473-17-00, enrolled 1005 participants and studied clinical remission at Week 12 and Week 52 using the Modified Mayo Score.[6][8]
A completed Phase 2 ulcerative colitis study, NCT04996797, enrolled 75 people and focused on safety, tolerability, and clinical remission at Week 12. Its remission measure used the 3-component Modified Mayo Score, which includes stool frequency, rectal bleeding, and endoscopy findings.[7]
Another authorised Phase 3 study, 2025-523766-25-00, enrolled 988 participants and also measured clinical remission with the Modified Mayo Score at Week 12 and Week 52. The source data also includes a Phase 3 Crohn’s disease or ulcerative colitis study, 2024-513533-20-00, which plans to evaluate long-term safety and tolerability in 1050 participants.[3][9]
Other conditions studied
Tulisokibart is also being studied in several non-bowel inflammatory diseases. These include radiographic axial spondyloarthritis, rheumatoid arthritis, hidradenitis suppurativa, systemic sclerosis associated with interstitial lung disease, and psoriatic arthritis.[4][5][10][11][12]
The Phase 2 study in radiographic axial spondyloarthritis, NCT2025-521059-21-00, plans to enroll 327 participants and measures ASAS 40 response at Week 16. ASAS 40 is a response score used to show improvement in symptoms and function.[4]
The Phase 2 rheumatoid arthritis study, 2025-521745-25-00, plans to enroll 199 people and measures ACR20 at Week 12. ACR20 means at least a 20% improvement in several arthritis signs and symptoms.[5]
The Phase 4 hidradenitis suppurativa study, 2024-520039-33-00, plans to enroll 208 participants and measures HiSCR50 at Week 16. HiSCR50 is a response measure for this skin condition and means a 50% clinical response.[10]
The Phase 2 systemic sclerosis associated with interstitial lung disease study, NCT05270668, plans to enroll 152 participants and compares the annual rate of change in forced vital capacity, or FVC, over 50 weeks. FVC is a lung function test that shows how much air a person can breathe out.[11]
The Phase 2 psoriatic arthritis study, 2025-520997-21-00, plans to enroll 146 participants and measures ACR20 at Week 16. This shows that the trial is looking for improvement in arthritis symptoms in people with psoriatic arthritis.[12]
Trial design and phases
Most of the studies are placebo-controlled, meaning Tulisokibart is compared with a placebo so researchers can see whether the treatment works better than no active study drug. The source data also shows different ways of giving the study treatment, including intravenous infusion, subcutaneous injection, subcutaneous use, and other listed use types.[1][2][3][4][5][7][10][11][12]
The Phase 2 studies are mainly looking at early signs of benefit and safety. The Phase 3 studies are larger and focus more on confirming benefit, while the Phase 4 study looks at later-stage use in hidradenitis suppurativa.[1][2][3][4][5][7][8][9][10][11][12]
What the endpoints mean
A primary endpoint is the main result researchers want to measure in a study. In these trials, the endpoints include safety, adverse events, clinical remission, endoscopic response, and disease-specific response scores.[1][2][3][4][5][7][8][9][10][11][12]
Safety and tolerability means researchers check whether people have unwanted medical problems, including adverse events, serious adverse events, or abnormal lab results. Several Tulisokibart studies use these measures as key outcomes.[2][3][7][11]
Endoscopic response and scores like SES-CD and Modified Mayo Score are important because they help show whether inflammation inside the bowel has improved. Other scores such as CDAI, ACR20, ASAS 40, and HiSCR50 help measure response in different diseases in a more standard way.[1][2][4][5][7][10][12]
Who may join these studies
People who may join these studies are those who already have the condition being studied, such as Crohn’s disease, ulcerative colitis, or one of the other listed inflammatory diseases. The source data does not give full eligibility rules, so the exact age limits, disease severity rules, and other requirements are not shown here.[1][2][3][4][5][6][7][8][9][10][11][12]
Because the studies are different, the people who can take part may also be different from one trial to another. The best fit depends on the disease, the trial phase, and the study design.[1][2][3][4][5][6][7][8][9][10][11][12]
