A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Prurigo Nodularis

Treatments: Drug: Placebo; Drug: Rocatinlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06527404

20230053

Details and patient eligibility

About

The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

Enrollment: 460 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years)
• Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months.
• Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to day 1.
• Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk.
• History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).

Exclusion criteria

• Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed).
• Prurigo nodularis secondary to medications.
• Prurigo nodularis secondary to neurologic or psychiatric medical conditions.
• Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization.
• Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 4 patient groups

Arm A: Blinded Treatment

Experimental group

Description:

Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.

Treatment:

Drug: Rocatinlimab

Arm B: Blinded Treatment

Experimental group

Description:

Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.

Treatment:

Drug: Rocatinlimab

Arm C: Blinded Treatment

Experimental group

Description:

Participants will receive matching placebo SC during Treatment Period A and B.

Treatment:

Drug: Placebo

Arm D: Open-label

Experimental group

Description:

Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.

Treatment:

Drug: Rocatinlimab