Continued TAK-279 treatment in adults with ulcerative colitis or Crohn's disease

A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants With Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn's Disease

Adults with moderate to severe ulcerative colitis or Crohn's disease who responded to earlier TAK-279 can continue TAK-279 for up to two years to see if it remains safe and lowers bowel inflammation and symptoms.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 183 (estimated)
• Ages: 18 Years to 76 Years
• Sex: All
• Sponsor: Takeda (industry)
• Locations: 16 sites (Glen Burnie, Maryland and 15 other locations)
• Trial ID: NCT06764615 on ClinicalTrials.gov

What this trial studies

This is an extension for adults who completed the parent TAK-279 Phase 2 trials and were clinical or symptomatic responders at Week 52, allowing them to continue TAK-279 treatment for up to 108 weeks. Participants will have about 11 clinic visits during the treatment period to monitor safety, symptoms, and bowel inflammation. The study focuses primarily on long-term safety and durability of response while collecting data on symptom control and inflammatory markers. Entry requires completion of the parent trial with valid electronic diary data and documented response at Week 52.

Who should consider this trial

Good fit: Adults with moderately to severely active ulcerative colitis or Crohn's disease who completed Week 52 of the parent TAK-279 trials and showed a clinical or symptomatic response are eligible.

Not a fit: Patients who did not respond to TAK-279 in the parent trials or who have medical reasons that prevent continued use of the drug are unlikely to benefit from this extension.

Why it matters

Potential benefit: If successful, long-term TAK-279 could maintain symptom control and reduce bowel inflammation with an understood safety profile over two years.

How similar studies have performed: Long-term extension programs of other JAK inhibitors for inflammatory bowel disease have shown durable symptom control and manageable safety profiles, supporting the general approach though TAK-279 itself is still being characterized.

Eligibility criteria

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.

   Disease-Specific Inclusion Criteria:
2. Completion of Week 52 in the parent phase 2 CD and UC trials 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 in PRO2 at parent trial Week 52, 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 parent trial Week 52, 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.

   Other General Inclusion Criteria:
4. 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.

   Exclusion Criteria related to Laboratory Investigations:
3. Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol.

   Exclusion criteria related to other prohibited concomitant medication:
4. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.

Where this trial is running

Glen Burnie, Maryland and 15 other locations

• Woodholme Gastroenterology Associates — Glen Burnie, Maryland, United States (RECRUITING)
• Tyler Research Institute, LLC — Tyler, Texas, United States (RECRUITING)
• Chongqing General Hospital — Chongqing, Chongqing Municipality, China (RECRUITING)
• The First Affiliated Hospital of Sun Yat-sen University — Guangdong, Guangdong, China (RECRUITING)
• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• Renji Hospital Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
• Hepato-Gastroenterologie HK s.r.o. — Hradec Králové, Czechia (RECRUITING)
• Pannonia Maganorvosi Centrum — Budapest, Hungary (RECRUITING)
• St. Antonius Ziekenhuis — Tilburg, North Brabant, Netherlands (RECRUITING)
• Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj — Torun, Kuyavian-Pomeranian Voivodeship, Poland (RECRUITING)
• Centrum Medyczne MedykSp. z o.o. Sp. K. — Lublin, Poland (RECRUITING)
• Twoja Przychodnia - Szczecinskie Centrum Medyczne — Szczecin, Poland (RECRUITING)
• WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland (RECRUITING)
• Endomed — Košice, Slovakia (RECRUITING)
• Inje University Haeundae Paik Hospital — Haeundae, Busan Gwangyeogsi, South Korea (RECRUITING)
• Yonsei University Wonju Severance Christian Hospital — Wŏnju, Gangwon-do, South Korea (RECRUITING)

Study contacts

• Study coordinator: Takeda Contact

Conditions: Crohn's Disease, Ulcerative Colitis, Drug Therapy