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Ro7790121

Clinical trials are studying Ro7790121 in several immune-related diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and atopic dermatitis. These studies are looking at how well it works, how safe it is, and whether it helps people with moderate to severe disease or people who did not respond to other treatments.

Table of Contents

Trials overview

The clinical trial program for Ro7790121 includes studies in several diseases linked to inflammation and immune system activity.[1] The trials are testing whether the treatment can improve disease control compared with placebo, which is an inactive treatment used for comparison.[1][2]

Most studies are in Phase 2 or Phase 3.[1][2] Phase 2 studies are usually smaller and help researchers learn more about safety and early effectiveness, while Phase 3 studies are larger and often compare the study drug with placebo in a more detailed way.[1][2]

Rheumatoid arthritis study

One Phase 2 study is testing Ro7790121 in people with moderate to severe rheumatoid arthritis who have not responded to, or cannot tolerate, TNF and/or JAK inhibitors.[1] TNF and JAK inhibitors are other treatments used for this disease, so this study focuses on people whose disease has been hard to treat.[1]

The study plans to enroll 160 participants and is authorised.[1] The main outcome is the change from baseline in DAS28-CRP at Week 14, which is a score that measures how active rheumatoid arthritis is using joint findings and a blood marker of inflammation.[1]

Crohn’s disease studies

Several trials are studying Ro7790121 in Crohn’s disease, including people with moderately to severely active disease.[2][3][4]

One Phase 3 induction study includes 429 participants and looks at whether Ro7790121 can help start a response in active Crohn’s disease.[2] Its main outcomes are clinical remission, defined as a Crohn’s Disease Activity Index score below 150, and endoscopic response, defined as at least a 50% decrease in Simple Endoscopic Score for Crohn’s Disease from baseline.[2]

Another Phase 3 study includes 604 participants and tests induction and maintenance therapy in moderately to severely active Crohn’s disease.[3] This means the study looks at both starting treatment and keeping disease under control over time.[3] Its main outcomes are the same remission and endoscopic response measures used in the other Crohn’s disease study.[3]

A Phase 2 multicenter, double-blind, two-arm study includes 77 participants with moderate to severe active Crohn’s disease.[4] Double-blind means that neither the participants nor the study team know who receives which treatment during the study, which helps reduce bias.[4] The main safety outcomes are the number of treatment-emergent adverse events, serious adverse events, and events that lead to stopping treatment.[4]

Ulcerative colitis studies

Ro7790121 is also being studied in ulcerative colitis, another inflammatory bowel disease.[5][8] Two Phase 3 studies are listed for people with moderately to severely active disease.[5][8]

One induction study includes 350 participants and uses intravenous infusion, which means the treatment is given through a vein.[5] The main outcome is clinical remission at Week 12, defined by a modified Mayo Score of 2 or less, with low stool frequency, no rectal bleeding, and a low endoscopic score.[5]

Another Phase 3 study includes 400 participants and looks at induction and maintenance therapy in moderately to severely active ulcerative colitis.[8] The brief summary says the study is designed to evaluate whether Ro7790121 can help induce and maintain clinical remission compared with placebo.[8]

Atopic dermatitis studies

Ro7790121 is also being studied in atopic dermatitis, which is a long-term skin condition that can cause itching and inflamed skin.[6][7] The trial data include one Phase 2 study in moderate to severe atopic dermatitis and one long-term Phase 2 follow-up study in people who already took part in previous Ro7790121 trials.[6][7]

The Phase 2 efficacy study plans to enroll 160 participants and compares Ro7790121 with placebo.[6] Its main outcome is the proportion of participants who reach an EASI-75 response at Week 16, meaning at least a 75% improvement in eczema area and severity.[6]

The long-term study includes 125 participants and focuses on safety and tolerability over time.[7] It measures the number and severity of adverse events, serious adverse events, treatment stoppages due to side effects, and adverse events of special interest.[7]

Outcomes and measures

The trials use disease-specific outcome measures to judge whether Ro7790121 is helping.[1][2][5][6]

  • DAS28-CRP is used in rheumatoid arthritis to measure how active the disease is.[1]
  • CDAI and SES-CD are used in Crohn’s disease to measure symptoms and bowel healing seen on scope examination.[2][3]
  • Modified Mayo Score is used in ulcerative colitis to measure disease activity and remission.[5]
  • EASI-75 is used in atopic dermatitis to show major skin improvement.[6]
  • Adverse events are health problems that happen during a study, and serious adverse events are the more severe ones.[4][7]

Who can participate

Eligibility depends on the disease being studied and the specific trial.[1][2][5][6]

  • People with moderate to severe rheumatoid arthritis may be included if they have not responded to, or cannot tolerate, TNF and/or JAK inhibitors.[1]
  • People with moderately to severely active Crohn’s disease may join the Crohn’s studies.[2][3]
  • People with moderately to severely active ulcerative colitis may join the ulcerative colitis studies.[5][8]
  • People with moderate to severe atopic dermatitis may join the skin disease studies, and one long-term study is for people who already took part in earlier Ro7790121 trials.[6][7]

Safety and long-term follow-up

Safety is an important part of the Ro7790121 trial program.[4][7] Some studies mainly measure safety and tolerability, while others measure both safety and how well the treatment works.[4][6][7]

The long-term atopic dermatitis study is especially focused on ongoing safety, including adverse events that lead to stopping treatment and adverse events of special interest.[7] This kind of follow-up helps researchers learn how the treatment performs over a longer period.[7]

Trial IDPhaseCondition studiedStatusEnrollment
2025-521034-28-00Phase 2Moderate to severe rheumatoid arthritisAuthorised160
2024-513054-30-00Phase 3Moderately to severely active Crohn’s diseaseAuthorised429
2024-513053-69-00Phase 3Moderately to severely active Crohn’s diseaseAuthorised604
NCT05910528Phase 2Crohn’s diseaseAuthorised77
2024-515494-95-00Phase 2Moderate to severe atopic dermatitisAuthorised160
2024-513015-27-00Phase 3Moderately to severely active ulcerative colitisAuthorised350
2025-520771-59-00Phase 2Atopic dermatitisAuthorised125
2024-513014-35-00Phase 3Moderately to severely active ulcerative colitisAuthorised400

FAQ

  • What conditions are being studied with Ro7790121? The trials are studying Ro7790121 in moderate to severe rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and atopic dermatitis. Most studies focus on people with active disease that is not well controlled.
  • What phases are the Ro7790121 trials in? The trial data include Phase 2 and Phase 3 studies. Phase 2 trials usually look at early effectiveness and safety, while Phase 3 trials compare the treatment with placebo in larger groups.
  • Who can take part in these studies? People with moderate to severe disease may be eligible, depending on the trial. One rheumatoid arthritis study includes patients who did not respond to or cannot tolerate TNF and/or JAK inhibitors, and one atopic dermatitis study includes people who took part in earlier Ro7790121 trials.
  • What are the main goals of the trials? The main goals are to measure clinical remission, disease improvement, and safety. Some studies also look at endoscopic response, which means improvement seen during a scope exam of the bowel.
  • How is success measured in these trials? The trials use different outcome measures, such as DAS28-CRP for rheumatoid arthritis, CDAI and SES-CD for Crohn’s disease, modified Mayo Score for ulcerative colitis, and EASI-75 for atopic dermatitis. These scores help show whether symptoms and inflammation improve.

Ongoing Clinical Trials on Ro7790121

  • Study on the Effectiveness and Safety of RO7790121 for Patients with Moderate to Severe Crohn’s Disease

    Recruiting

    1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia France +8

  • A study testing RO7790121 for moderate to severe rheumatoid arthritis in patients who did not respond to or cannot tolerate TNF or JAK inhibitor treatments

    Recruiting

    1
    Investigated drugs:
    Belgium Denmark France Germany Italy Poland +1

  • A study to evaluate the long-term safety and effectiveness of afimkibart in patients with atopic dermatitis who took part in previous afimkibart studies

    Recruiting

    1
    Investigated drugs:
    France Germany Italy Poland Spain

  • Study of RO7790121 (afimkibart) for Treatment and Long-term Management in Adults with Moderate to Severe Crohn’s Disease

    Recruiting

    1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +10

  • Long‑Term Safety and Efficacy of RO7790121 in Adults with Moderate to Severe Rheumatoid Arthritis: Extension Study

    Not yet recruiting

    1
    Investigated drugs:
    Belgium Denmark France Germany Italy Poland +1

  • Study on the Effectiveness and Safety of RO7790121 for Patients with Moderate to Severe Atopic Dermatitis

    Not recruiting

    1
    Investigated drugs:
    France Germany Italy Poland Spain

  • Study of RVT-3101 for Treating Moderate to Severe Crohn’s Disease in Patients

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Hungary +5

  • Study of RO7790121 Compared to Placebo for Treatment of Adults with Moderate to Severe Ulcerative Colitis

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +10

  • Study of RO7790121 Treatment for Adults with Moderate to Severe Ulcerative Colitis: Testing Effectiveness and Safety in Initial and Long-term Therapy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +10

Glossary

  • Interventional study: A type of clinical trial where participants receive a study treatment so researchers can see what happens.
  • Phase 2: An earlier trial phase that looks at safety and whether the treatment may work.
  • Phase 3: A later trial phase that tests the treatment in larger groups and compares it with placebo or standard care.
  • Placebo: An inactive treatment used for comparison in a trial.
  • Clinical remission: A state where signs and symptoms of disease are very low or absent.
  • DAS28-CRP: A score used in rheumatoid arthritis to measure disease activity using joint findings and C-reactive protein, a blood marker of inflammation.
  • CDAI: Crohn’s Disease Activity Index, a score used to measure how active Crohn’s disease is.
  • SES-CD: Simple Endoscopic Score for Crohn’s Disease, a score based on bowel scope findings.
  • Modified Mayo Score: A score used to measure ulcerative colitis activity.
  • EASI-75: A measure showing at least 75% improvement in eczema severity and area.
  • Adverse event: A health problem that happens during a study, whether or not it is caused by the study treatment.
  • Serious adverse event: A more severe health problem during a study, such as one that is life-threatening or needs hospital care.

References

  1. https://clinicaltrials.gov/study/2025-521034-28-00
  2. https://clinicaltrials.gov/study/2024-513054-30-00
  3. https://clinicaltrials.gov/study/2024-513053-69-00
  4. https://clinicaltrials.eu/trial/study-of-rvt-3101-for-treating-moderate-to-severe-crohns-disease-in-patients/
  5. https://clinicaltrials.gov/study/2024-513015-27-00
  6. https://clinicaltrials.gov/study/2024-515494-95-00
  7. https://clinicaltrials.gov/study/2025-520771-59-00
  8. https://clinicaltrials.gov/study/2024-513014-35-00