Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis

Genentech

Status and phase: Completed; Phase 2

Conditions: Prurigo Nodularis; Pruritis

Treatments: Drug: Placebo; Drug: Vixarelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03816891

KPL-716-C201

GS45044 (Other Identifier)

Details and patient eligibility

About

Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis (PN).

Full description

This is a Phase 2a/b randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, PK and immunogenicity of Vixarelimab administered subcutaneously (SC) in subjects with prurigo nodularis experiencing pruritus.

Phase 2a portion:

Forty-nine subjects with moderate to severe PN experiencing moderate to severe pruritus are treated in the Phase 2a portion of the study. At Baseline, subjects are randomized 1:1 to receive double-blind (DBL) vixarelimab or placebo: vixarelimab 720 mg loading dose followed by 360 mg every week; placebo loading dose followed by placebo every week. The treatment period is 8 weeks or 16 weeks (treatment duration was reduced from 16 weeks to 8 weeks in a protocol amendment [Protocol Version 3]).

Phase 2b portion:

The Phase 2b study consists of a 4-week Screening Period and a 16-week Double-Blind Period, followed by a 36-week Open-Label-Extension (OLE) Period. Approximately 180 subjects with PN, experiencing severe pruritus, are randomized (at 1:1:1:1 ratio) into one of 4 arms (3 active arms and one placebo arm). A total of 4 doses of study drug are administered during the Double-Blind Period to measure the efficacy, safety, and PK of Vixarelimab. After the Double-Blind Period, all subjects have the option to receive vixarelimab during the OLE Period to evaluate the long-term safety and PK.

Enrollment: 240 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified):

1. Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b)
2. Have clinical diagnosis of prurigo nodularis for at least 6 months
3. Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the Screening Visit and Day 1
4. Moderate to severe pruritus (Phase 2a); severe pruritus (Phase 2b)
5. Female subjects of childbearing potential must have a negative pregnancy test, be nonlactating, and having agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 16 weeks after final study drug administration
6. Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study

Exclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified):

1. Use of prohibited medications within the indicated timeframe from Day 1
2. Is currently using medication known to cause pruritus
3. Presence of any inflammatory, pruritic, and/or fibrotic skin condition other than moderate to severe prurigo nodularis or atopic dermatitis unless approved by the Sponsor
4. Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
5. Has an active infection, including skin infection
6. Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the subject at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 7 patient groups, including a placebo group

Phase 2a - Vixarelimab 360 mg SC Weekly (QW)

Experimental group

Description:

Vixarelimab 720 mg loading dose followed by 360 mg weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)

Treatment:

Drug: Vixarelimab

Phase 2a - Placebo SC QW

Placebo Comparator group

Description:

Placebo loading dose followed by placebo weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)

Treatment:

Drug: Placebo

Phase 2b - Vixarelimab 540 mg SC Every 4 Weeks (Q4W; DBL)

Experimental group

Description:

Vixarelimab 540 mg SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period

Treatment:

Drug: Vixarelimab

Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL)

Experimental group

Description:

Vixarelimab 360 mg SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period

Treatment:

Drug: Vixarelimab

Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL)

Experimental group

Description:

Vixarelimab 120 mg SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period

Treatment:

Drug: Vixarelimab

Phase 2b - Placebo SC, Q4W (DBL)

Placebo Comparator group

Description:

Placebo SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period

Treatment:

Drug: Placebo

Phase 2b - Vixarelimab 360 mg SC, Every 2 Weeks (Q2W; OLE)

Experimental group

Description:

Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension

Treatment:

Drug: Vixarelimab