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

3 septembre 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

44

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Australie
    • Victoria
      • Melbourne, Victoria, Australie, 3004
        • Complété
        • Nucleus Network
  • Chine
      • Beijing, Chine
        • Recrutement
        • Peking University Third Hospital
        • Contact:
      • Guangzhou, Chine
        • Recrutement
        • The third affiliated hospital of Sun Yat-Sen University
        • Contact:
      • Guangzhou, Chine
        • Recrutement
        • Guangdong Provincial People's Hospital
        • Contact:
      • Nanchang, Chine
        • Recrutement
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Chine
        • Recrutement
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Nanjing, Chine
        • Recrutement
        • Nanjing Drum Tower Hospital
        • Contact:
      • Pingxiang, Chine
        • Recrutement
        • Pingxiang People's Hospital
        • Contact:
  • Corée du Sud
      • Seoul, Corée du Sud
        • Recrutement
        • Seoul National University Hospital
        • Contact:
  • Mexique
      • Chihuahua City, Mexique
        • Recrutement
        • Hospital Angeles Chihuahua
        • Contact:
      • San Nicolás de los Garza, Mexique
        • Recrutement
        • Unidad Médica para la Salud Integral (UMSI)
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Part 1: Placebo
Matching SC placebo administered to randomized Part 1 participants
Autre: Placebo
Matching placebo comparator for Part 1 participants.
Expérimental: Part 1: PRO-203
Healthy participants receive single ascending dose of PRO-203 in dose escalation cohorts
Médicament: PRO-203
PRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.
Expérimental: 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.
Médicament: PRO-203
PRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of Adverse Events and Laboratory Abnormalities [Safety and Tolerability]
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pharmacokinetics of PRO-203
Délai: 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
Délai: 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
Délai: 13 weeks (Part 1) / 49 weeks (Part 2)
Level of anti-drug antibodies
13 weeks (Part 1) / 49 weeks (Part 2)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
FVC % Predicted (Part 2)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Prolium Bioscience, Inc

Les enquêteurs

  • Directeur d'études: Salim Mujais, Prolium Bioscience, Inc

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 octobre 2025

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 janvier 2028

Dates d'inscription aux études

Première soumission

10 décembre 2025

Première soumission répondant aux critères de contrôle qualité

7 juin 2026

Première publication (Réel)

11 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PRO-203-101

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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