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New treatment option for Pulmonary Arterial Hypertension PAH
Official title A Phase Ⅰb/Ⅱa Clinical Study of IMC-003 Injection for the Treatment of Pulmonary Arterial Hypertension Receiving Background Therapy.
ClinicalTrials.gov ID: NCT07593027
What this study is testing
What is IMC-003 and PAH background therapy?
IMC-003 and PAH background therapy is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pulmonary arterial hypertension pah.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase Ib/IIa clinical study of IMC-003 treatment in pulmonary arterial hypertension (PAH) patients receiving background therapy
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants aged 18-75 years old (inclusive), any gender;
- Patients diagnosed with WHO Group 1 pulmonary arterial hypertension (PAH) via right heart catheterization (RHC) before dosing (see Appendix 1)...
- Idiopathic PAH;
- Heritable PAH;
- Drug- or toxin-induced PAH;
You likely can't join if
- 1) Diagnosed with WHO Group 2, 3, 4, or 5 pulmonary hypertension. 2) Diagnosed with the following PAH subtypes in WHO Group 1:
- HIV-associated PAH
- Portal hypertension-associated PAH
- Schistosomiasis-associated PAH
- PAH associated with pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
- PAH patients with known positive acute pulmonary vasoreactivity test 3) History of echocardiogram within 6 months before screening showing left...
See the full eligibility criteria
- Participants aged 18-75 years old (inclusive), any gender;
- Patients diagnosed with WHO Group 1 pulmonary arterial hypertension (PAH) via right heart catheterization (RHC) before dosing (see Appendix 1), including the following subtypes:
- Idiopathic PAH;
- Heritable PAH;
- Drug- or toxin-induced PAH;
- Inactive, connective tissue disease-associated PAH;
- Simple congenital heart disease with left-to-right shunt-related PAH, at least 1 year post-repair surgery;
- Symptomatic pulmonary arterial hypertension, WHO functional class II or III ;
- Must also meet the following hemodynamic criteria:
- Mean pulmonary arterial pressure (mPAP) at rest ≥25 mmHg;
- Pulmonary arterial wedge pressure (PAWP) ≤15 mmHg;
- Pulmonary vascular resistance (PVR) measured by RHC within 10 days before initial dosing ≥5 Wood Units (400 dyn sec cm-5), prior RHC results before screening are acceptable if they meet study requirements;
- Receiving stable doses of background PAH therapy (i.e., for at least 90 days before first dosing, individualized target doses for each therapy reached and stable); for subcutaneous prostacyclin users, a 10% variation...
- Background PAH therapy refers to approved PAH-specific drugs, including ERA and/or PDE-5i or sGC stimulators and/or prostacyclin analogs or receptor agonists (subcutaneous). Note: PAH background therapy drugs should...
- During screening and within 10 days before first dosing, the mean of two 6-minute walk distance (6MWD) tests should be ≥150m and ≤450m, with a maximum difference of 15% (based on the higher value); the two tests should...
- Female participants of childbearing potential must have a negative serum pregnancy test before dosing, agree to regular urine or serum pregnancy tests during treatment (any one), use highly effective contraception...
- Male participants agree to use condoms, defined as using latex condoms or non-latex condoms made from non-natural (animal) membranes (e.g., polyurethane) during sexual activity with pregnant women or women of...
- Participants understand and follow the study procedures, voluntarily participate, and sign the informed consent form.
- 1) Diagnosed with WHO Group 2, 3, 4, or 5 pulmonary hypertension. 2) Diagnosed with the following PAH subtypes in WHO Group 1:
- HIV-associated PAH
- Portal hypertension-associated PAH
- Schistosomiasis-associated PAH
- PAH associated with pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
- PAH patients with known positive acute pulmonary vasoreactivity test 3) History of echocardiogram within 6 months before screening showing left ventricular ejection fraction \ 160 mmHg or seated diastolic BP \>100 mmHg...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Jilin City, Changchun, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Guiyang, Guizhou, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Jinan, Shangdong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Jilin City, Changchun, China; Fuzhou, Fujian, China; Xiamen, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.