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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

1 Nov 2024 → ongoing

Decision date (initial)

2024-10-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Amgen Inc.

External identifiers

EU CT number

2024-510753-10-00

WHO UTN

U1111-1304-4631

ClinicalTrials.gov

NCT06527404

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of different doses of rocatinlimab compared with placebo at specified timepoints on the PRO measure of pruritus

Secondary objectives 5

1. To evaluate the efficacy of different doses of rocatinlimab compared with placebo at specified timepoints using investigator's assessment on prurigo nodularis
2. To evaluate the efficacy of different doses of rocatinlimab compared with placebo at specified timepoints on the PRO measure of pruritus
3. To evaluate the efficacy of different doses of rocatinlimab compared with placebo at specified timepoints on the PRO measure of prurigo nodularis skin pain
4. To evaluate the efficacy of different doses of rocatinlimab compared with placebo at specified timepoints on the PRO measure of pruritus and investigator's assessment on prurigo nodularis
5. To characterize the safety and tolerability of rocatinlimab in adult participants with prurigo nodularis.

Conditions and MedDRA coding

Prurigo Nodularis

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available on the Amgen Clinical Trials portal (http://www.amgen.com/datasharing).”

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Participant has provided informed consent before initiation of any study-specific activities/procedures.
2. Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
3. A clinical diagnosis of prurigo nodularis (as defined by core symptoms according to the United States expert panel consensus [Elmariah et al, 2021]), that has been present for at least 3 months before signing of informed consent. The prurigo nodularis defined core symptoms include pruritus for more than 6 weeks, evidence of chronic scratching, and presence of multiple pruriginous lesions and excoriated nodules.
4. Patient-reported average itching score based on electronic daily diary assessment the last 7 days prior to day 1, at day 1 prerandomization.
5. Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs, and/or both arms and/or trunk at initial screening and at day 1 prerandomization.
6. Prior to informed consent, history of inadequate response topical therapies for prurigo nodularis or for whom topical therapies is otherwise medically inadvisable (eg, because of important side effects or safety risks). - Inadequate response is defined as inability to achieve and/or maintain a low disease state despite treatment with a daily regimen of topical therapies, - Participants with any previous systemic treatment or phototherapy for prurigo nodularis or topical Janus kinase (JAK) inhibitors for prurigo nodularis, independent of response, are also considered as inadequate responders and are potentially eligible to be included in the study after appropriate washout.
7. Participants must have completed at least 4 days of daily diary entries within the 7 days preceding and including day 1 prerandomization.

Exclusion criteria 23

1. Skin or systemic morbidities, other than prurigo nodularis, that have been active or requiring treatment within the last 3 months, prior to screening that interfere with the assessment of study outcomes
2. History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
3. Superficial skin infection within 2 weeks before day 1 prerandomization.
4. Known sensitivity to any of the products or components to be administered during dosing.
5. Major psychiatric illness,within 1 year before day 1 prerandomization.
6. Inpatient psychiatric admission within 1 year before day 1 prerandomization.
7. Change in psychiatric medication for a psychiatric illness within 8 weeks before day 1 prerandomization.
8. Anticipated need to change psychiatric medication for a psychiatric illness during the study.
9. History of alcohol or substance abuse within 6 months prior to initial screening.
10. Any of the following laboratory abnormalities at initial screening: - eGFR < 30 mL/min/1.73 m2 - AST or ALT: ≥ 2.5 times the upper limit of normal (ULN) - neutrophil count: < 1.5 x 103/µL
11. Diagnosis of a helminth parasitic infection within 6 months prior to day 1 prerandomization that had not been treated with or had failed to respond to standard of care therapy.
12. Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals within the specified time period before day 1 prerandomization.
13. History of New York Heart Association class III/IV heart failure; diagnosis of uncontrolled hypertension at initial screening; or inadequately treated cardiovascular conditions at initial screening including: cardiomyopathy, major congenital heart disease, or second or third-degree atrioventricular block.
14. Recent cardiovascular events including cerebrovascular accident, myocardial infarction, coronary stenting, or unstable angina within 6 months of day 1 prerandomization
15. Evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
16. Positive for HCV antibody at initial screening with confirmed positive HCV RNA.
17. Chronic hepatitis B infection at initial screening, defined as detectable HBsAg or HBV DNA.Participants with detectable anti-HBc and negative HBsAg/HBV DNA are required to do on-study HBV DNA monitoring.
18. Active or latent tuberculosis infection as evident by positive or indeterminate QuantiFERON GOLD from central laboratory at initial screening and assessed at day 1 prerandomization per Screening TB Risk Assessment Questionnaire provided by Amgen.
19. A corrected QT interval (QTc ) of > 450 msec in males of > 470 msec in females at screening as assessed by the investigator, or history of long QT syndrome.
20. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted,would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
21. Prurigo nodularis secondary to medications.
22. Prurigo nodularis secondary to neurologic or psychiatric medical conditions
23. Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Achieving reduction from baseline in weekly average of daily itching score at specified time points.

Secondary endpoints 6

1. Improvement in investigator assessment of PN lesions
2. Improvement in daily itching from baseline.
3. Improvement in daily skin pain from baseline
4. Change in quality of life from baseline.
5. Change in sleep disturbance from baseline
6. Treatment-emergent adverse events , adverse events of special interest, and serious adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1730

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 14

Locations

15 EU/EEA countries · 71 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Urgent safety measures 1 · Art. 54 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 204 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications