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A Phase Ⅰb/Ⅱa Clinical Study of IMC-003 Injection for the Treatment of Pulmonary Arterial Hypertension Receiving Background Therapy.

ConditionPulmonary Arterial Hypertension PAH
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

About this trial

This is a Phase Ib/IIa clinical study of IMC-003 treatment in pulmonary arterial hypertension (PAH) patients receiving background therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants aged 18-75 years old (inclusive), any gender;

Idiopathic PAH;

Heritable PAH;

Drug- or toxin-induced PAH;

Disqualifiers

HIV-associated PAH

Portal hypertension-associated PAH

Schistosomiasis-associated PAH

PAH associated with pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • IMC-003 and PAH background therapy

    Drug

    Subjects will receive 8 injections of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.

  • IMC-003 placebo and PAH background therapy

    Drug

    Subjects will receive 8 injections placebo of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental: IMC-003Active comparator 1 intervention
Group B: placebo of IMC-003Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Phase Ib

Primary Endpoints * Safety and Tolerability: Incidence and frequency of adverse events (AEs) and serious adverse events (SAEs) (according to CTCAE v6.0 from NCI); * abnormalities in vital signs, physical exams（The units for height are centimeters and for weight are kilograms ）, lab tests, 12-lead ECG, echocardiography, etc., before and after medication. Primary Efficacy Endpoint \- Change in hemodynamic indicator pulmonary vascular resistance (PVR) from baseline at Week 24 of treatment.

Time frame
24 weeks
2

Phase IIa

Primary efficacy endpoint: \- Change in hemodynamic parameter pulmonary vascular resistance (PVR) from baseline after 24 weeks of treatment. Safety endpoints: * Occurrence and frequency of AE and SAE; * Any abnormalities in vital signs, physical exams（The units for height are centimeters and for weight are kilograms ）, lab tests, 12-lead ECGs, and echocardiograms before and after treatment.

Time frame
24 weeks

Secondary outcomes

1

Proportion of participants meeting composite improvement criteria . Other hemodynamic-related changes. Changes in heart MRI-related indicators. Changes in 6MWD. Changes in WHO FC classification. Changes in NT-proBNP. The rate at which the disease worsens

1. At 24 weeks of treatment, the proportion of participants who achieved the composite improvement criteria : * Six-minute walk distance increased by ≥30 meters from baseline * NT-proBNP decreased by ≥30% from baseline, or NT-proBNP levels remained/achieved \<300 ng/L * WHO functional class improved by at least 1 level from baseline, or maintained at WHO FC II 2. At 24 weeks of treatment, changes in other hemodynamic-related indicators from baseline 3. At 24 weeks of treatment, changes in heart-related MRI indicators from baseline 4. After treatment, assess the change in 6MWD from baseline at the end of the 2nd, 4th, 6th, and 8th treatment cycles 5. After treatment, the change in WHO functional class from baseline at the end of each treatment cycle 6. After treatment, the change in NT-proBNP from baseline at the end of each treatment cycle 7. The rate of disease progression at 24 weeks of treatment

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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