Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

Aerovate Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: AV-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05557942

AV-101-003

Details and patient eligibility

About

IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (AV-101-002, NCT#05036135) were offered the opportunity to continue into this LTE study. Subjects who enrolled in the study were to receive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study.

Enrollment: 186 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

To be eligible, a participant is required to be or have:

• Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.

Key Exclusion Criteria:

Subjects meeting any of the following criteria:

• The Investigator believes that it would not be in the best interest of the subject to be included in the LTE e.g., for clinical or social reasons.
• Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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186 participants in 6 patient groups

Placebo Crossover AV-101 10 mg

Experimental group

Description:

Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.

Treatment:

Drug: AV-101

Placebo Crossover AV-101 35 mg

Experimental group

Description:

Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.

Treatment:

Drug: AV-101

Placebo Crossover AV-101 70 mg

Experimental group

Description:

Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.

Treatment:

Drug: AV-101

Continuing AV-101 10 mg

Experimental group

Description:

Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.

Treatment:

Drug: AV-101

Continuing AV-101 35 mg

Experimental group

Description:

Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.

Treatment:

Drug: AV-101

Continuing AV-101 70 mg

Experimental group

Description:

Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.

Treatment:

Drug: AV-101