臨床研究等提出・公開システム

A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies

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

Torralba Karina

Amgen

One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA

ktorralb@amgen.com

Clinical trial information contact

Kyowa Kirin Co., Ltd.

1-9-2, Otemachi , Chiyoda-ku, Tokyo

+81-3-5205-7200

clinical.info.jp@kyowakirin.com

Pending

Sept. 30, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Age >= 18 years
2. Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months.
3. Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to day 1.
4. Has >= 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk.
5. 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).

1. 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).
2. Prurigo nodularis secondary to medications.
3. Prurigo nodularis secondary to neurologic or psychiatric medical conditions.
4. 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.
5. Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.

Both

Prurigo Nodularis

Arm A: Blinded Treatment
Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.
Arm B: Blinded Treatment
Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.
Arm C: Blinded Treatment
Participants will receive matching placebo SC during Treatment Period A and B.
Arm D: Open-label
Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.

Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24

1. Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 24
2. Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24
3. Number of Participants Achieving Reduction in Weekly Average Daily Prurigo Nodularis Skin Pain Assessment at Week 24 in Those with Baseline NRS Above Cutoff
4. Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 16
5. Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 16
6. Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 24
7. Change from Baseline in Weekly Average of Daily Itch Score at Week24
8. Change from Baseline in Prurigo Nodularis Assessment Score at Week24
9. Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Week 24 in Participants with Baseline Score Greater Than a Cutoff Score
10. Change from Baseline in Quality of Life Assessment Score at Week 24
11. Change from Baseline in Quality of Life Assessment Score at Week 16
12. Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 24
13. Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24
14. Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24 in Participants with Baseline Weekly Average Score Greater Than a Cutoff Score
15. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
16. Number of Participants Experiencing AEs of Special Interest (EOIs)
17. Number of Participants with Anti-rocatinlimab Antibodies
18. Serum Concentrations of Rocatinlimab
19. Trough Concentration (Ctrough) of Rocatinlimab

Yes

Following Amgen's process, de-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Further details are available at the URL (http://www.amgen.com/datasharing).

United States