A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn’s Disease (CD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Takeda Development Center Americas Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

27 Aug 2025 → ongoing

Decision date (initial)

2025-05-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Takeda Development Center Americas, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Crohn’s Disease (CD) or Ulcerative Colitis (UC): To assess the long-term safety and tolerability of oral zasocitinib in participants with moderately to severely active CD or UC who meet response criteria at Week 52 in the parent phase 2 CD or UC trials (TAK‑279-CD-2001 and TAK-279-UC-2001, respectively), and receive long-term treatment of zasocitinib for up to 108 weeks.

Secondary objectives 3

1. 1. CD: To evaluate long-term efficacy of zasocitinib in achieving clinical remission, clinical response, endoscopic response and endoscopic remission over time in participants with moderately to severely active CD who meet response criteria at Week 52 in the parent phase 2 CD trial (TAK-279-CD-2001), and receive long-term treatment of zasocitinib for up to 108 weeks.
2. 2. UC: To evaluate the long-term efficacy of zasocitinib in achieving clinical remission, clinical response, symptomatic remission, and endoscopic changes over time in participants with moderately to severely active UC who meet response criteria at Week 52 in the parent phase 2 UC trial (TAK 279-UC-2001) and receive long-term treatment of zasocitinib for up to 108 weeks.
3. 3. CD or UC: To evaluate the effect of zasocitinib on patient-reported symptoms and disease-specific HRQoL in participants with moderately to severely active CD and UC who meet response criteria at Week 52 in the parent phase 2 CD or UC trials (TAK‑279-CD-2001 and TAK-279-UC-2001, respectively), and receive long‑term treatment of zasocitinib for up to 108 weeks.

Conditions and MedDRA coding

Moderate to Severely Active Ulcerative Colitis & Moderate to Severely Active Crohn's Disease

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Pharmaceuticals And Medical Devices Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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. 2. Completion of Week 52 in the parent phase 2 CD and UC trials with valid eDiary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001). If eDiary data is not available at Week 52, prior scores may be used upon consultation with the medical monitor.
3. 3. Clinical or symptomatic responder at parent trial Week 52 as defined below: a) TAK-279-CD-2001: Clinical response in PRO2 at parent trial Week 52, assessed as ≥30% decrease in average daily very soft or liquid stools and/or ≥decrease in average AP from parent trial baseline. b) TAK-279-UC-2001: Symptomatic response at parent trial Week 52, assessed as a reduction in pmMS of ≥1 points and ≥30% from parent trial baseline; and a decrease from parent trial baseline in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point.
4. 4. Participants are nonpregnant, nonlactating or of nonchildbearing potential. For individuals of reproductive potential, if sexually active, agree to comply with the contraceptive requirements for the duration of the trial and 10 days after the last dose of the trial intervention. The following birth control requirements must be met: a) Effective contraception for male (sex-assigned at birth) participants (male condom) is required from the signing of informed consent throughout the duration of the trial and for 10 days after the last dose of the trial intervention. b) Female (sex-assigned at birth) participants must be surgically sterile or be of nonchildbearing potential with confirmation of postmenopausal status (ie, follicle-stimulating hormone [FSH] level >40 mIU/mL); or, if sexually active with a nonsterilized individual who produces sperm agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the trial and for 10 days after the last dose.

Exclusion criteria 6

1. 1. Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.
2. 2. Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE
3. 3. Are pregnant, nursing, or planning pregnancy while in the OLE trial or within 10 days of the trial intervention after the last dose of the trial intervention.
4. 4. Participant has inadequate renal or hepatic function before enrollment based on the following parameters: a) Total bilirubin (unconjugated and/or conjugated) ≥1.5 × upper limit normal (ULN) unless the participant has known Gilbert’s syndrome that can explain the elevation of bilirubin, or b) Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × ULN, or c) Creatinine >1.5 × ULN. d) Estimated creatinine clearance <45 mL/min based on the Cockcroft-Gault calculation. e) Participant with elevated lipase and/or amylase >3 × ULN. Participants with elevated lipase and/or amylase >2 × ULN will require further workup such as radiological imaging and physical examination to rule out a diagnosis of acute pancreatitis. Once a diagnosis of acute pancreatitis has been completely ruled out, then the participant can be included in the trial. f) Participants with a history of chronic pancreatitis or recent acute pancreatitis (<60 days/ not fully resolved).
5. 5. Participant with any of the following laboratory values at or prior to enrollment: a) Hemoglobin <9.0 g/dL (<90.0 g/L) b) Absolute white blood cell count <3.0 × 109/L (<3000/mm3) c) Absolute neutrophil count of <1.2 × 109/L (<1200/mm3) d) Absolute lymphocyte count of <0.75 × 109/L (<750/mm3) e) Platelet count <100 × 109/L f) Triglyceride level ≥750 mg/dL (≥8.5 mmol/L) g) Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial. h) Creatine phosphokinase (CPK) > ULN. CPK may be repeated once; if repeat value is CTCAE Grade 1 or lower (or ≤2.5 × ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for modulating factors including concomitant medications or vigorous exercise that may affect CPK levels.
6. 6. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 1. Incidence of treatment-emergent adverse events (TEAEs) by indication.
2. 2. Clinically significant changes in vital signs, clinical laboratory parameters, electrocardiogram by indication.
3. 3. Incidence of adverse events of special interest (AESIs) by indication.

Secondary endpoints 16

1. 1. Clinical remission by visit, assessed as proportion of participants achieving CD Activity Index (CDAI) <150.
2. 2. Clinical response by visit, assessed as proportion of participants achieving reduction of CDAI from baseline (defined as baseline in parent phase 2 CD trial) of >100.
3. 3. Endoscopic response at annual assessments at Week 48 and Week 108, assessed as proportion of participants achieving decrease in simplified endoscopic score for CD (SES-CD) >50% from baseline (defined as baseline in parent phase 2 CD trial) (or for participants with isolated ileal disease, SES-CD <4 or at least a 2-point from baseline read centrally).
4. 4. Endoscopic remission at annual assessments at Week 48 and Week 108, assessed as proportion of participants achieving SES-CD <4 or <2 for ileal disease.
5. 5. Clinical remission in two patient-reported outcome items (PRO2) of the CDAI by visit, assessed as proportion of participants with average daily liquid or very soft stool frequency (SF) score ≤2.8 and not worse than baseline (defined as baseline in parent phase 2 CD trial) and average daily abdominal pain (AP) score ≤1 and not worse than baseline (defined as baseline in parent phase 2 CD trial).
6. 6. Clinical response in PRO2 by visit, assessed as proportion of participants with ≥30% decrease in average daily very soft or liquid stools and/ or ≥30% decrease in average AP from baseline (defined as baseline in parent phase 2 CD trial).
7. 1. Clinical remission at annual assessments (Week 48 and Week 108), assessed as proportion of participants achieving a modified Mayo Score (mMS) of ≤2 with SF subscore of ≤1, rectal bleeding subscore of 0, and centrally read endoscopic subscore of ≤1 (score of 1 modified to exclude friability).
8. 2. Clinical Response at annual assessments (Week 48 and Week 108), assessed as the proportion of participants achieving a reduction from baseline (defined as baseline in parent phase 2 UC trial) in mMS of ≥2 points and ≥30% from baseline (defined as baseline in parent phase 2 UC trial) and a decrease from baseline in the rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point.
9. 3. Symptomatic remission by visit, assessed as the proportion of participants achieving a rectal bleeding subscore of 0 and SF subscore of Mayo score of ≤1.
10. 4. Endoscopic improvement at annual assessments (Week 48 and Week 108), assessed as the proportion of participants achieving a modified Mayo endoscopic subscore of ≤1 (score of 1 to exclude friability).
11. 5. Endoscopic remission at annual assessments (Week 48 and Week 108), assessed as the proportion of participants achieving a modified Mayo endoscopic subscore of 0.
12. 1. Proportion of participants with no bowel urgency by visit as measured by the bowel urgency eDiary item.
13. 2. Proportion of participants with no AP by visit as measured by the AP eDiary item.
14. 3. Change from baseline (defined as baseline in parent phase 2 CD or UC trials) in fatigue as measured by the FACIT-Fatigue score by visit.
15. 4. Disease-specific HRQoL as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) total score by visit, assessed as the proportion of participants with total score ≥170.
16. 5. Change from baseline (defined as baseline in parent phase 2 CD or UC trials) in disease‑specific HRQoL by visit as measured by the IBDQ total score.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Takeda Development Center Americas Inc.

Sponsor organisation

Takeda Development Center Americas Inc.

Address

500 Kendall Street

City

Cambridge

Postcode

02142-1108

Country

United States

Scientific contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Namita Singh

Public contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Takeda

Third parties 14

Locations

14 EU/EEA countries · 91 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 131 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications