Crohn's Disease, Ulcerative Colitis
Conditions
Keywords
Drug Therapy
Brief summary
Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation. This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461), TAK-279-UC-2001 (NCT06254950) and TAK-279-CD-2003 (NCT07403968). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study. The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD. The participants will be treated with TAK-279 for up to 3 years (156 weeks). During the study, participants will visit their study clinic around 15 times.
Interventions
DRUGZasocitinib
Zasocitinib capsules.
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator. The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization prior to the initiation of any trial procedures. 2. Completion of Week 52 in the parent trials (phase 2b CD and phase 2 UC) with valid electronic (e) Diary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001). 3. Clinical or symptomatic responder at parent trial Week 52 as defined below: 1. TAK-279-CD-2001: Clinical response at Week 52 of the parent trial based on PRO2, assessed as \>=30% decrease in average daily very soft or liquid stools and/ or \>=30% decrease in average AP from parent trial baseline. 2. TAK-279-UC-2001: Symptomatic response at Week 52 of the parent trial, assessed as a reduction in partial modified Mayo score (pmMS) of \>=1 points and \>=30% from parent trial baseline; and a decrease from parent trial baseline in the rectal bleeding sub-score of \>=1 point or an absolute rectal bleeding sub-score of \<=1 point. 4. TAK-279-CD-2003: Endoscopic response at Week 12 of the parent trial, assessed as a participant achieving decrease in SES-CD \>50% from baseline (or for participants with isolated ileal disease, SES-CD \<=4 or at least a 2-point reduction from baseline). Other General Inclusion Criteria: 5. Participants must meet the contraception recommendations.
Exclusion criteria
1. Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns. 2. Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) | From start of study drug administration up to Week 160 (current study) | TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate. |
| All Cohorts: Number of Participants With Clinically Significant Changes in Vital Sign Values | From start of study drug administration up to Week 160 (current study) | Vital sign values include body temperature, respiratory rate, sitting blood pressure (systolic and diastolic, resting more than 5 minutes), pulse (beats per minute). Clinical significance of vital signs will be determined at the investigator's discretion. |
| All Cohorts: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values | From start of study drug administration up to Week 160 (current study) | Laboratory parameters include hematology, clinical chemistry and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion. |
| Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values | At Day 1 and Week 156 (current study) | ECGs will be performed with the participant in the supine or semi-supine position and after resting comfortably for at least 5 minutes. Clinical significance of 12-lead ECG values will be determined at the investigator's discretion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Percentage of CD Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) | Up to Week 156 (current study) | Clinical remission is defined as a CDAI score of less than (\<) 150 points. |
| Cohort 1: Percentage of CD Participants Achieving Clinical Response Based on the CDAI | Up to Week 156 (current study) | Clinical response is defined as greater than (\>) 100-point decrease from parent study baseline in CDAI score. |
| Cohort 1: Percentage of CD Participants Achieving Decrease in Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) | At Weeks 48, 108, and 156 (current study) | Endoscopic response is defined by decrease in SES-CD \>50 percent (%) from baseline (defined as % baseline in parent study TAK-279-CD-2001 \[NCT06233461\]) (or for participants with isolated ileal disease, SES-CD less than or equal to (=\<) 4 or at least a 2-point reduction from baseline). The SES-CD score ranges from 0 to 56 which includes 4 endoscopic variables (intestinal surface affected by ulcers, intestinal surface affected by other inflammatory lesions, presence of ulcers, and presence of narrowing). |
| Cohort 1: Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD | At Weeks 48, 108, and 156 (current study) | Endoscopic remission is defined as SES-CD score =\< 4 or =\< 2 for ileal disease, no sub-score \>1. The SES-CD score ranges from 0 to 56 which includes 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing). |
| Cohort 1: Percentage of CD Participants With Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) | Up to Week 156 (current study) | Clinical remission based on PRO2 is defined as average daily liquid or very soft stool frequency (SF) score less than or equal to (\<=) 2.8 and not worse than parent study baseline and average daily abdominal pain (AP) score \<=1 and not worse than baseline. |
| Cohort 1: Percentage of CD Participants With a Clinical Response in PRO2 | Up to Week 156 (current study) | Clinical response based on PRO2 is defined as greater than or equal to (\>=) 30% decrease in average daily very soft or liquid stools and/ or \>=30% decrease in average AP from parent study baseline. |
| Cohort 2: Percentage of UC Participants Achieving Clinical Remission Based on Modified Mayo Score (mMS) | At Weeks 48, 108, and 156 (current study) | The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component sub-score ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined as Mayo RB sub-score of 0, Mayo SF sub-score of 0 or 1, and ES sub-score 1 or 0 (score of 1 modified to exclude friability). |
| Cohort 2: Percentage of UC Participants Achieving Clinical Response Based on mMS | At Weeks 48, 108, and 156 (current study) | Clinical response is defined as reduction from parent study baseline in mMS of \>=2 points and \>=30% from parent study baseline and a decrease from parent study baseline in the RB sub-score of \>=1 point or an absolute RB sub-score of \<=1 point. |
| Cohort 2: Percentage of UC Participants Achieving a Symptomatic Remission | Up to Week 156 (current study) | Symptomatic remission is defined as RB sub-score of 0 and SF sub-score of Mayo score \<=1. |
| Cohort 2: Percentage of UC Participants Achieving Endoscopic Improvement Based on Modified Mayo Endoscopic Sub-score (ES) | At Weeks 48, 108, and 156 (current study) | Endoscopic improvement is defined as a modified Mayo ES of \<=1 (score of 1 modified to exclude friability). |
| Cohort 2: Percentage of UC Participants Achieving Endoscopic Remission Based on Modified Mayo (ES) | At Weeks 48, 108, and 156 (current study) | Endoscopic remission is defined as a modified Mayo ES of 0. |
| Cohorts 1 and 2: Percentage of CD or UC Participants With no Bowel Urgency | Up to Week 156 (current study) | Bowel urgency is measured by the bowel urgency electronic diary (eDiary) item. |
| Cohorts 1 and 2: Percentage of UC or CD Participants With no Abdominal Pain | Up to Week 156 (current study) | Abdominal pain is measured by abdominal pain eDiary item. |
| Cohorts 1 and 2: Change From Baseline in Fatigue in UC or CD Participants as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score | Up to Week 156 (current study) | The FACIT-Fatigue is a reliable and valid instrument for measuring fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue. |
| Cohorts 1 and 2: Percentage of UC or CD Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 | Up to Week 156 (current study) | The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel systems (10 items), emotional function (12 items), systemic function (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life. |
| Cohorts 1 and 2: Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) in UC or CD Participants as Measured by IBDQ Total Score | Up to Week 156 (current study) | The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel systems (10 items), emotional functional (12 items), systemic function (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life. |
Countries
China, Czechia, Hungary, Netherlands, Poland, Slovakia, South Korea, United States
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed