A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis
A Phase IIa, Multicenter, Single-Arm Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Characteristics of PTT-621 in Patients With Moderately to Severely Active Ulcerative
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Ran Wei
- Telefonnummer: +86 10 81938094
- E-mail: ran.wei@pyrotech.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200127
- Renji Hospital-Shanghai Jiao Tong University School of Medicine
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Kontakt:
- Qi Lu
- Telefonnummer: +86 21 68383575
- E-mail: rjirbzc@vip.163.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
1. Male or female participants aged 18-70 years inclusive at screening. 2. Diagnosed with ulcerative colitis (UC) at least 60 days prior to the first dose of IP.
3. Participants have active UC at screening, defined as a modified Mayo score of 5-9.
4. Endoscopic evidence of UC extending ≥15 cm from the anal verge during the screening period.
5. Participants have had inadequate/loss of response or intolerance to at least one of the following: 5-aminosalicylic acid, glucocorticoids, immunosuppressants, biologics, and/or small-molecule targeted therapies.
6. Participants currently receiving the following UC therapies are eligible if they meet stability requirements: Oral glucocorticoids: with stable dosing for ≥2 weeks prior to screening endoscopy；Oral 5-ASA: Stable dose for at least 2 weeks prior to the endoscopic assessment during the screening period.
7. Female participants of childbearing potential must have a negative serum/urine pregnancy test at screening.
8. Willing to use at least one highly effective contraceptive method during sexual intercourse throughout the study and until 1 month after the last dose of IP.
9. Willing to refrain from sperm/ova donation throughout the study and until 1 month after the last dose of IP.
10. Able and willing to provide written informed consent and comply with all protocol-specified procedures and visit schedules.
Exclusion Criteria:
- 1. A current diagnosis of Crohn's disease (CD), indeterminate colitis, infectious colitis, or any other colitis/enteritis that could interfere with efficacy evaluation； 2. Has UC complications (e.g., fulminant colitis, toxic megacolon, prior total or partial colectomy, or other conditions requiring surgery)； 3. Prior or current gastrointestinal dysplasia； 4. History of gastrointestinal malignancy, or any current evidence of gastrointestinal cancer.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Participants receiving PTT-621 Dose A
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PTT-621 will be administered orally
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of participants achieving endoscopic improvement at Week 12
Tidsramme: Week 12
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Week 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of participants with adverse events (AEs)
Tidsramme: Baseline, Week 2, 4, 8, 12
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Baseline, Week 2, 4, 8, 12
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Percentage of participants achieving clinical remission、clinical response
Tidsramme: Week 12
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Week 12
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Percentage of participants achieving symptom remission, symptom response
Tidsramme: Weeks 2, 4, 8, 12
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Weeks 2, 4, 8, 12
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Pharmacokinetic (PK) characteristics: Plasma concentrations of PTT-621
Tidsramme: Baseline, Weeks 2, 4, 8, 12
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Baseline, Weeks 2, 4, 8, 12
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Changes in fecal calprotectin from baseline
Tidsramme: Weeks 2, 4, 8, 12
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Weeks 2, 4, 8, 12
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Changes in high-sensitivity C-reactive protein (hsCRP) from baseline
Tidsramme: Week 2, 4, 8, 12
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Week 2, 4, 8, 12
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PTT-621-201
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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