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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
- Age screening between 18 and 75 years (inclusive), regardless of gender.
- Patients diagnosed with WHO Group 1 pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC) before initial dosing (see...
- Symptomatic pulmonary arterial hypertension, WHO functional class II or III.
- Must also meet the following hemodynamic criteria: mean pulmonary arterial pressure (mPAP) ≥25 mmHg at rest; pulmonary artery wedge pressure (PAWP)...
- Pulmonary vascular resistance (PVR) ≥5 Wood Units (400 dyn sec cm-5) by RHC before the first dose, results from pre-screening RHC are acceptable (if...
You likely can't join if
- Diagnosed with pulmonary hypertension of WHO Group 2, 3, 4, or 5.
- Diagnosed with the following PAH subtypes of WHO Group 1: HIV-associated PAH, portal hypertension-associated PAH, schistosomiasis-associated PAH, PAH...
- Poorly controlled hypertension after screening: seated systolic BP \>160 mmHg or seated diastolic BP \>100 mmHg, or pre-dose systolic BP \<90 mmHg on...
- Pre-dose electrocardiogram (ECG) Fridericia-corrected QT interval (QTcF) ≥470 ms for men, ≥480 ms for women; or personal or family history of long QT...
- Untreated mild or more severe obstructive sleep apnea.
- Previously underwent or plans to undergo heart or cardiopulmonary transplantation, or expected lifespan \<12 months as assessed by the investigator.
See the full eligibility criteria
- Age screening between 18 and 75 years (inclusive), regardless of gender.
- Patients diagnosed with WHO Group 1 pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC) before initial dosing (see Appendix 1), including the following subtypes: idiopathic PAH...
- Symptomatic pulmonary arterial hypertension, WHO functional class II or III.
- Must also meet the following hemodynamic criteria: mean pulmonary arterial pressure (mPAP) ≥25 mmHg at rest; pulmonary artery wedge pressure (PAWP) ≤15 mmHg.
- Pulmonary vascular resistance (PVR) ≥5 Wood Units (400 dyn sec cm-5) by RHC before the first dose, results from pre-screening RHC are acceptable (if they meet the study requirements).
- Receiving stable doses of background PAH therapy (i.e., each therapy's individualized target dose has been achieved and stable for at least 90 days before initial dosing).
- Six-minute walk distance (6MWD) during screening ≥150 meters and ≤450 meters.
- Female participants of childbearing potential must have a negative serum pregnancy test before dosing and agree to undergo regular urine or serum pregnancy tests (any one) during the treatment period; agree to use...
- Male participants agree to use condoms, defined as using latex condoms or non-latex (non-animal membrane) condoms (e.g., polyurethane) during sexual intercourse with pregnant or childbearing potential women during...
- Participants understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
- Diagnosed with pulmonary hypertension of WHO Group 2, 3, 4, or 5.
- Diagnosed with the following PAH subtypes of WHO Group 1: HIV-associated PAH, portal hypertension-associated PAH, schistosomiasis-associated PAH, PAH related to pulmonary veno-occlusive disease or pulmonary capillary...
- Poorly controlled hypertension after screening: seated systolic BP \>160 mmHg or seated diastolic BP \>100 mmHg, or pre-dose systolic BP \<90 mmHg on C1D1.
- Pre-dose electrocardiogram (ECG) Fridericia-corrected QT interval (QTcF) ≥470 ms for men, ≥480 ms for women; or personal or family history of long QT syndrome (LQTS) or sudden cardiac death.
- Untreated mild or more severe obstructive sleep apnea.
- Previously underwent or plans to undergo heart or cardiopulmonary transplantation, or expected lifespan \<12 months as assessed by the investigator.
- Diagnosed with chronic obstructive pulmonary disease (COPD) or other clinically significant lung disease.
- Evidence of interstitial lung disease (ILD) based on chest CT within 1 year before screening or pulmonary function test (PET) within 6 months before screening will lead to exclusion; if the above tests are not...
- Pre-dose hemoglobin (Hb) above the sex-specific upper limit of normal (ULN) or \ 3 × ULN, total bilirubin \>1.5 × ULN, estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m\^2.
- History of portal hypertension or chronic liver disease, including Hepatitis B Surface Antigen (HBsAg) positive, and/or Hepatitis B Core Antibody (HBcAb) positive and Hepatitis Bvirus-Deoxyribonucleic acid HBV-DNA)...
- are participating in other clinical studies; or have participated in clinical studies of medical devices or other drugs within 30 days before screening (except for those who have only signed the ICF and have not...
- Previous treatment targeting the TGF-β superfamily (e.g., Sotatercept) (including participation in a clinical trial).
- Known participant has a prior allergy to macromolecular protein preparations/monoclonal antibodies, known hypersensitivity to the investigational drug or its excipients, or the same type of drug.
- History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia within 6 months prior to dosing); Severe local infection (e.g., cellulitis, abscess) or systemic infection (e.g., sepsis) within 4...
- History of malignancy or current malignancy (excluding basal cell carcinoma that has been resected with no evidence of metastatic disease for 3 years, or cervical intraepithelial neoplasia that has been treated and is...
- History of chronic kidney disease prior to screening, or acute renal failure requiring acute dialysis within 3 months prior to screening, regardless of whether there was a previous history of kidney disease.
- Females who are pregnant or breastfeeding.
- Participants who are considered unsuitable for the study in the opinion of the investigator.
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
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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.
Explore other conditions
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.