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Clinical Research Trials of Florida, Inc. | Tampa, FL

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

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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 1prerandomization.
  • 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

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

Trial contacts and locations

39

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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