A study on targeted treatments for adult patients with Crohn's disease
Descrizione riassuntiva dello studio
This study evaluates targeted therapies for patients with moderate to severe Crohn's disease. Targeted treatments are medications that aim at specific activities in the body to improve symptoms and treat the underlying disease. Participants will be randomly assigned to a treatment group at the beginning of the study using a computer program (randomized). The current study treatments are open-label, meaning that both the participants and the investigators know which treatment is being administered to the participants. Over time, study treatments may be added or removed. Thus, the investigators can determine if the study treatments elicit the expected response in the participants and should be further investigated.
(BASEC)
Intervento studiato
The medications used in this study are Risankizumab, ABBV 382, and Lutikizumab. Risankizumab and ABBV-382 are administered as a subcutaneous injection or as an intravenous infusion. Lutikizumab is administered as a subcutaneous injection. When participants are enrolled in the study, they are randomized into available treatment groups. Each group includes a 12-week induction period (treatment to improve symptoms), a 12-week maintenance period (treatment to prevent recurrence or worsening of symptoms), and an optional long-term extension period during which treatment with Risankizumab is administered after the maintenance period. Participation in the long-term extension period, which lasts an additional 72 weeks, is determined by the investigator. Participants will undergo study-related procedures throughout the study, which may include questionnaires, X-rays, endoscopies, and blood tests.
(BASEC)
Malattie studiate
Crohn's disease is a chronic condition that causes severe inflammation (redness, swelling) in the gastrointestinal tract, most commonly affecting the intestines. It can cause many different symptoms, including abdominal pain, diarrhea, fatigue, and weight loss. Treatments are available, but they do not work equally for all patients or may stop working over time.
(BASEC)
This study includes patients aged 18 to 75 years with a confirmed diagnosis of Crohn's disease for at least 3 months. Participants must have had an inadequate response to at least one or more available treatments. (BASEC)
Criteri di esclusione
- Complications of Crohn's disease (e.g., abscesses and/or strictures in the intestine) - Active or suspected malignant disease or history of malignant disease within the last 5 years - Patients who have undergone a major surgical procedure within 3 months prior to participation in the study or are planned during the study - Pregnancy (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
AbbVie Inc., North Chicago, USA AbbVie AG, Cham, CH
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Franzisca Rusca (AbbVie Medical Information)
+41 41 399 16 89
franzisca.rusca@clutterabbvie.comAbbVie Medical Information
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
17.12.2024
(BASEC)
ID di studio ICTRP
NCT06548542 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease (BASEC)
Titolo accademico
A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease (ICTRP)
Titolo pubblico
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease (ICTRP)
Malattie studiate
Crohn's Disease (ICTRP)
Intervento studiato
Drug: RisankizumabDrug: LutikizumabDrug: TrosunilimabDrug: RisankizumabDrug: TrosunilimabDrug: ABBV-8736 (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Participants' body weight must be >= 40 kg at Baseline.
- Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of
biopsy results consistent with the diagnosis of CD as assessed by the Investigator
must be available.
- CDAI >= 220 at Baseline.
- Endoscopic evidence of mucosal inflammation as documented by an SES-CD of >= 6 for
ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease. All
eligible scores exclude the presence of narrowing component and are determined by a
reader.
- Participants must demonstrate intolerance or inadequate response to conventional
therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.
Exclusion Criteria:
- Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
- Participant who received any investigational TaT (or TaT that becomes approved
during the conduct of the study) within 30 days or 5 half-lives prior to Baseline,
whichever is longer. Note: If there is documentation of an undetectable (or below
the lower limit of quantification/quantitation) drug level measured by a
commercially available assay for any of the approved biologics above, there is no
minimum washout prior to Baseline.
- Participant who have any of the following: Current diagnosis of UC or indeterminate
colitis. Currently known complications of CD such as: Current ostomy or ileoanal
pouch Current short gut or short bowel syndrome Surgical bowel resection within
the past 3 months prior to Baseline. (ICTRP)
non disponibile
Endpoint primari e secondari
Percentage of Participants who Achieve Endoscopic Remission (ICTRP)
Percentage of Participants who Achieve Endoscopic Response;Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS);Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
ABBVIE INC.;ABBVIE CALL CENTER;Site Coordinator, abbvieclinicaltrials@abbvie.com, 844-663-3742;478-742-2600, AbbVie, (ICTRP)
ID secondari
2024-513009-30, 2024-513009-30-00, M24-885 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06548542 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile