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A Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.

3 settembre 2026 aggiornato da: Prolium Bioscience, Inc

A Two-part, Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study of PRO-203 in Healthy Adult Volunteers Followed by an Open-label, Single-ascending-dose With Priming Study of PRO-203 in Participants With Systemic Sclerosis

A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This two-part study is designed to characterize the first-in-human safety, tolerability, PK, and PD profile of PRO-203 across ascending dose levels.

Part 1 - Healthy Volunteers (HV) Part 1 enrollment is complete and has enrolled 20 healthy volunteers across 3 cohorts. Participants within each cohort received a single SC dose of PRO-203 or matching placebo. Part 1 has completed enrollment.

Part 2 - Systemic Sclerosis (SSc) Up to 24 participants with SSc will be enrolled in multiple cohorts (with optional additional cohorts) Participants within each cohort will receive a single SC cycle of PRO-203. Part 2 includes a Main Study and an optional Long-term Extension (LTE). In the LTE, eligible participants may receive retreatment if they meet retreatment criteria. Total study duration per participant is up to 53 weeks.

Tipo di studio

Interventistico

Iscrizione (Stimato)

44

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Completato
        • Nucleus Network
  • Cina
      • Beijing, Cina
        • Reclutamento
        • Peking University Third Hospital
        • Contatto:
      • Guangzhou, Cina
        • Reclutamento
        • The third affiliated hospital of Sun Yat-Sen University
        • Contatto:
      • Guangzhou, Cina
        • Reclutamento
        • Guangdong Provincial People's Hospital
        • Contatto:
      • Nanchang, Cina
        • Reclutamento
        • The First Affiliated Hospital of Nanchang University
        • Contatto:
      • Nanchang, Cina
        • Reclutamento
        • The Second Affiliated Hospital of Nanchang University
        • Contatto:
      • Nanjing, Cina
        • Reclutamento
        • Nanjing Drum Tower Hospital
        • Contatto:
      • Pingxiang, Cina
        • Reclutamento
        • Pingxiang People's Hospital
        • Contatto:
  • Corea del Sud
      • Seoul, Corea del Sud
        • Reclutamento
        • Seoul National University Hospital
        • Contatto:
  • Messico
      • Chihuahua City, Messico
        • Reclutamento
        • Hospital Angeles Chihuahua
        • Contatto:
      • San Nicolás de los Garza, Messico
        • Reclutamento
        • Unidad Médica para la Salud Integral (UMSI)
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Key Inclusion Criteria (All Participants)

  • Is male or female, age 18 to 65 years, inclusive, at Screening.
  • Able to provide Informed Consent.
  • Absolute B cell count > 25 cells/uL.

Additional Inclusion for Part 1 (Closed to Enrollment)

  • In good general health, determined by no clinically significant findings in the of the investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1 (participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment).
  • Up to date vaccination status per local guidelines (including but not limited to influenza vaccine, COVID booster and hepatitis B vaccine).

Additional Inclusion for Part 2

  • Fulfill 2013 ACR/ EULAR criteria for classification of SSc with a total score of ≥ 9.
  • Active disease defined as at least two of the following at screening:
  • Disease duration ≤ 2 years (since onset of first-non-Raynaud-symptom), or
  • Elevated acute phase reactant levels (CRP ≥ 6 mg/L, erythrocytes sedimentation rate [ESR] ≥ 28 mm/1h, or platelet count ≥ 330,000/µL), or
  • Baseline mRSS ≥10 with evidence of progression, defined as mRSS increase at least 3 units, or involvement of 1 new body area and mRSS increase at least 2 units, or involvement of 2 new body areas (each within the previous 6 months), or
  • ≥ 1 tendon friction rub, or
  • Elevation of CK or aldolase > 2 × the upper limit of normal (ULN) consistent with SSc-related myopathy, or

  • Progressive fibrosing interstitial lung disease (ILD) as defined by at least one of the following criteria at any time within the prior 2 years:

    1. relative decline in forced vital capacity (FVC) % predicted ≥ 10%, or
    2. relative decline in FVC % predicted ≥ 5% to <10% and worsened respiratory symptoms, or
    3. relative decline in FVC % predicted ≥ 5% to <10% and increased extent of fibrosis on high-resolution computed tomography (HRCT), or
    4. worsened respiratory symptoms and increased extent of fibrosis on HRCT
  • Intolerant or refractory to at least 1 line of standard therapy, including methotrexate, azathioprine, IVIG, mycophenolic acid derivatives, cyclophosphamide, TNF-inhibitors, rituximab, or tocilizumab.

Key Exclusion Criteria (All Participants)

  • Any clinically significant underlying illness in the opinion of the investigator.
  • Active infection within 4 weeks prior to screening. Participants receiving IV antibiotics or having received IV antibiotics within 14 days prior to enrollment are excluded.
  • Positive QuantiFERON-Gold TB test at screening.
  • Plan to receive live, attenuated vaccine after signing ICF (inactive vaccines, such as the flu vaccine, are allowed).
  • Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except for treated local basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that had been excised and cured).
  • Currently enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives of the prior investigational agent (whichever is longer) have passed since ending another investigational device or drug study or plans to enroll in another investigational device or drug study during the course of this study.
  • Social smokers e.g. up to 10 cigarettes per week (or equivalent amounts of nicotine containing products) and willing to abstain during inpatient stay, are allowed

Additional Exclusion Criteria for Part 1 (Closed to Enrollment)

  • Use of any prescription medication within 14 days and OTC medications, vitamins, herbal medications (e.g., St. John's wort), or cannabis, except for contraceptive medications and as needed (prn) acetaminophen/paracetamol (not exceeding 2 grams/day) within 7 days prior to administration of the study drug and throughout the study.

Additional Exclusion Criteria for Part 2

  • Rheumatic autoimmune disease other than SSc.
  • Positive anti-centromere antibodies.
  • Pulmonary disease with FVC ≤ 45% of predicted, or DLCO ≤ 35% of predicted.
  • Class 2 or higher pulmonary arterial hypertension or evidence of other moderately severe pulmonary disease.
  • Renal crisis within 6 months prior to Screening.
  • Prior treatment with cellular immunotherapy (eg, CAR-T) or gene therapy product directed at any target.
  • Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation.
  • Previous treatment with thalidomide, anti-thymocyte globulin, plasmapheresis, or extracorporeal photopheresis.
  • Unable to washout current immunosuppressive therapy within 2 months
  • Has received anti-CD19 or CD20 therapies, within 6 months prior to start of therapy
  • Plan to receive live or live-attenuated vaccines within 8 weeks prior to first dose of study drug and during treatment until B cell reconstitution to 80% of baseline (inactive vaccines, such as the flu vaccine, are allowed)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Part 1: Placebo
Matching SC placebo administered to randomized Part 1 participants
Altro: Placebo
Matching placebo comparator for Part 1 participants.
Sperimentale: Part 1: PRO-203
Healthy participants receive single ascending dose of PRO-203 in dose escalation cohorts
Droga: PRO-203
PRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.
Sperimentale: Part 2: Multiple Doses of PRO-203
Participants with systemic sclerosis receive a single cycle of PRO-203 across cohorts, including additional treatment as needed.
Droga: PRO-203
PRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Adverse Events and Laboratory Abnormalities [Safety and Tolerability]
Lasso di tempo: 13 weeks (Part 1) / 49 weeks (Part 2)
Incidence and severity of treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities, including changes in clinical laboratory values, ECGs, and vital signs.
13 weeks (Part 1) / 49 weeks (Part 2)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pharmacokinetics of PRO-203
Lasso di tempo: 13 weeks (Part 1) / 49 weeks (Part 2)
Serum drug levels of PRO-203 over time
13 weeks (Part 1) / 49 weeks (Part 2)
Pharmacodynamic-related biomarkers of PRO-203
Lasso di tempo: 13 weeks (Part 1) / 49 weeks (Part 2)
Peripheral blood B lymphocyte levels over time
13 weeks (Part 1) / 49 weeks (Part 2)
Immunogenicity of PRO-203
Lasso di tempo: 13 weeks (Part 1) / 49 weeks (Part 2)
Level of anti-drug antibodies
13 weeks (Part 1) / 49 weeks (Part 2)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
FVC % Predicted (Part 2)
Lasso di tempo: 13 weeks / 49 weeks
Change from baseline in forced vital capacity (FVC) as a percentage of predicted normal.
13 weeks / 49 weeks
Diffusing Capacity for Carbon Monoxide (DLCO) (Part 2)
Lasso di tempo: 13 weeks / 49 weeks
Change from baseline in diffusing capacity for carbon monoxide (DLCO) as a percentage of predicted normal.
13 weeks / 49 weeks
Modified Rodnan Skin Score (mRSS) (Part 2)
Lasso di tempo: 13 weeks /49 weeks
Change from baseline in Modified Rodnan Skin Score (mRSS) on a scale of 0 to 51, with a higher score indicating greater skin thickening.
13 weeks /49 weeks
Revised Composite Response Index in Systemic Sclerosis (rCRISS) (Part 2)
Lasso di tempo: 13 weeks / 49 weeks
Change from baseline in disease response as measured by the Revised Composite Response Index in Systemic Sclerosis (rCRISS), where a higher score indicates a better outcome.
13 weeks / 49 weeks
European Scleroderma Trials and Research Group Activity Index (EUSTAR-AI) (Part 2)
Lasso di tempo: 13 weeks / 49 weeks
Change from baseline in disease activity as measured by the European Scleroderma Trials and Research Group Activity Index (EUSTAR-AI) on a scale of 0 to 10, where a higher score indicates greater disease activity.
13 weeks / 49 weeks
Health Assessment Questionnaire - Disability Index (HAQ-DI) (Part 2)
Lasso di tempo: 13 weeks / 49 weeks
Change from baseline in physical function and disability as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) on a scale of 0 to 3, where a higher score indicates greater difficulty with daily activities.
13 weeks / 49 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Prolium Bioscience, Inc

Investigatori

  • Direttore dello studio: Salim Mujais, Prolium Bioscience, Inc

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 ottobre 2025

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

10 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PRO-203-101

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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