VPD-737 for Treatment of Chronic Pruritus

Vyne Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Pruritus

Treatments: Drug: VPD-737; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01951274

TCP 101

Details and patient eligibility

About

A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments

Full description

The sensation of itch is transmitted to the brain through the nervous system Several chemicals are involved in transmitting this signal This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial The trial will involve once daily pills for 6 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period Patients will also be monitored for safety and will have blood taken for testing and several points during the trial Overall participation will last about 12 weeks

Enrollment: 257 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of chronic pruritus and unresponsive to current therapies

Exclusion criteria

• Have chronic liver or renal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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257 participants in 4 patient groups, including a placebo group

0.25 mg VPD-737

Experimental group

Description:

0.25 mg of VPD-737 daily by mouth for 42 days

Treatment:

Drug: VPD-737

1 mg VPD-737

Experimental group

Description:

1 mg VPD-737 taken daily by mouth for 42 days

Treatment:

Drug: VPD-737

5 mg VPD-737

Experimental group

Description:

5 mg tablets of VPD-737 to be taken daily by mouth for 42 days

Treatment:

Drug: VPD-737

Placebo

Placebo Comparator group

Description:

placebo tablets to be taken daily by mouth for 42 days

Treatment:

Drug: Placebo