A Phase 3 interventional study of AJM300 and Placebo in Colitis, Ulcerative, sponsored by EA Pharma Co., Ltd.. Completed at 82 sites in Japan. Open to participants aged 16 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by EA Pharma Co., Ltd. (part of Eisai Co., Ltd.) · Phase 3, Interventional, and Treatment
The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative colitis.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's enrollment of 198 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →EA Pharma Co., Ltd. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Major Inclusion Criteria:
Participants with moderate ulcerative colitis who satisfy all of the following criteria at Day of enrollment.
Major Exclusion Criteria:
Participants with the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks.
Drug: AJM300
Participants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks.
Drug: Placebo
AJM300 film-coated tablets.
Also known as: Carotegrast methyl
Placebo matched to AJM300 tablets.
Clinical Response Rate Based on Mayo Score
Clinical response rate is defined by the percentage of participants who satisfy the combined definition of the change of the total value of Mayo score and the change or the actual value of individual subscales. Mayo score is used in clinical trials to assess ulcerative colitis (UC) disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Time frame: At Week 8
Clinical Remission Rate Based on Mayo Score
Clinical remission rate is defined by the percentage of participants with Mayo score \<=2 and no subscore greater than (\>) 1.
Time frame: At Week 8
Mucosal Healing Rate
Mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore \<=1.
Time frame: At Week 8
Complete Mucosal Healing Rate
Complete mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore =0.
Time frame: At Week 8
Clinical Response Rate Based on Partial Mayo Score
Clinical response rate is defined by the percentage of participants who satisfy the combined definition of the change of the total value of partial Mayo score and the change or the actual value of individual subscales. Partial Mayo score is used in clinical trials to assess UC disease activity. It consists of 3 subscales: stool frequency, rectal bleeding and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total partial Mayo score ranges from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Week 8
Clinical Remission Rate Based on Partial Mayo Score
Clinical remission rate is defined by the percentage of participants with partial Mayo score \<=2 and no subscore \>1.
Time frame: At Week 8
Modified Clinical Remission Rate 1
Modified Clinical remission rate 1 is defined by percentage of participants who satisfies the three conditions such as: rectal bleeding subscore =0, Stool frequency subscore =0 and Endoscopic subscore \<=1.
Time frame: At Week 8
Modified Clinical Remission Rate 2
Modified Clinical remission rate 2 is defined by the percentage of participants who satisfies the three conditions such as: rectal bleeding subscore =0, a decrease in the stool frequency subscore of at least 1 point or an absolute stool frequency subscore of 0 or 1 and Endoscopic subscore \<=1.
Time frame: At Week 8
Percentage of Rectal Bleeding Subscore of 0
Percentage of rectal bleeding subscore of 0 means the percentage of participants with rectal bleeding score =0.
Time frame: At Week 8
Change From Baseline in Mayo score
Mayo score is used in clinical trials to assess UC disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Time frame: Baseline, Week 8
Change From Baseline in Partial Mayo Score
Partial Mayo score is used in clinical trials to assess UC disease activity. It consists of 3 subscales: stool frequency, rectal bleeding and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total Mayo score ranges from 0 to 9, with higher scores indicating more severe disease.
Time frame: Baseline, Week 8
Change From Baseline in Fecal Calprotectin
Time frame: Baseline, Week 8
Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts)
Time frame: Baseline, Week 8
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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