Rocatinlimab Delivery Methods in Healthy Participants

No longer recruiting at 6 trial locations

Overseen By Amgen Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Arrhythmia, Hypertension, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the body absorbs a new treatment, rocatinlimab, when administered by two methods: an autoinjector and a traditional vial. The study aims to determine the most effective delivery method. It seeks healthy adults aged 18 to 60 with a body mass index (a measure of body fat based on height and weight) between 18 and 32. Participants must not have significant health issues or medication allergies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for this trial?

Yes, you will need to stop taking most over-the-counter or prescription medications 30 days or 5 half-lives before Check-in, except for acetaminophen, hormonal contraception, and hormone replacement therapy. Herbal medicines, vitamins, and supplements are also restricted unless approved by the Investigator.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that rocatinlimab is generally safe and well-tolerated. Earlier clinical trials found it safe compared to a placebo. Only 4% of participants experienced serious side effects, slightly higher than the 2% in the placebo group, but still considered acceptable.

Studies on both the vial solution and autoinjector forms of rocatinlimab have examined how the drug moves through the body and found no major safety issues. Repeated use of rocatinlimab in patients with moderate to severe atopic dermatitis (a type of skin condition) also demonstrated safety.

Overall, while the current trial remains in its early stages, previous research supports the safety of rocatinlimab in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about rocatinlimab because it offers innovative delivery methods for potential treatments. Unlike standard injections that can require a visit to a healthcare provider, rocatinlimab is being tested with a vial solution for subcutaneous injection and an autoinjector, both of which make it easier for patients to administer the treatment themselves. This convenience could enhance patient compliance and improve overall treatment experiences. Additionally, the unique delivery methods aim to maintain the effectiveness of rocatinlimab while providing flexibility and ease of use, which is a significant advancement over current options.

What evidence suggests that this trial's delivery methods for rocatinlimab could be effective?

Research has shown that rocatinlimab may help treat moderate-to-severe atopic dermatitis, a type of eczema. In studies, it performed better than a placebo, demonstrating real benefits. Both the vial solution and autoinjector forms have improved skin conditions. Previous trials reported positive results, highlighting its potential to help people with skin issues. In this trial, participants will be randomized to receive either the rocatinlimab vial solution or the autoinjector form to test these delivery methods in healthy participants. Although this specific trial focuses on delivery methods, the treatment itself has proven effective for atopic dermatitis in clinical settings. ^{1 3 4 5 6}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18-65 with a body mass index (BMI) between 18 and 32. Participants must consent to study procedures before starting.

Inclusion Criteria

Body mass index between 18 and 32 kg/m2 (inclusive)

Participant has provided informed consent before initiation of any study-specific activities/procedures

Exclusion Criteria

Alanine aminotransferase or aspartate aminotransferase > 1.5 times the upper limit of normal at Screening or Check-in

I have not received live vaccines recently and do not plan to within 3 months after starting the trial.

I have a history of significant heart rhythm problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of rocatinlimab via autoinjector or vial

1 day

1 visit (in-person)

Follow-up

Participants are monitored for treatment-emergent adverse events and any clinically significant changes in vital signs, ECG, and clinical laboratory tests

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rocatinlimab

Trial Overview The trial is testing the bioavailability of Rocatinlimab, an atopic dermatitis treatment, by comparing its absorption in the body when administered via autoinjector versus traditional vial.

How Is the Trial Designed?

Group I: Treatment B Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose of rocatinlimab autoinjector for SC injection.

Group II: Treatment A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose of rocatinlimab vial solution for SC injection.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

A population pharmacokinetic model developed from data of 546 patients in the Phase 1 GARNET trial showed that dostarlimab, an anti-PD-1 antibody, has a well-defined pharmacokinetic profile with a terminal elimination half-life of approximately 23.5 days.

The study found that while certain patient characteristics like age, body weight, and sex influenced the drug's clearance and distribution, there were no clinically significant exposure-response relationships for efficacy or safety, supporting the recommended dosing regimen for dostarlimab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics and exposure-response of anti-programmed cell death protein-1 monoclonal antibody dostarlimab in advanced solid tumours. Melhem, M., Hanze, E., Lu, S., et al.[2022]

In a meta-analysis of clinical trials, PD-1 inhibitors (like nivolumab and pembrolizumab) were found to have a higher incidence of colitis compared to PD-L1 inhibitors (like atezolizumab and durvalumab), with rates of 1.49% for all grade colitis and 0.85% for grade 3-4 colitis.

The analysis indicated that the relative risk of developing colitis with PD-1 inhibitors was significantly higher (1.80 for all grade colitis and 2.52 for grade 3-4 colitis), suggesting that patients receiving PD-1 inhibitors may need closer monitoring for this adverse effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and Risk of Colitis With Programmed Death 1 Versus Programmed Death Ligand 1 Inhibitors for the Treatment of Cancer. Miyashita, H., Mikami, T., Satoi, S., et al.[2021]

In a study of 196 cancer patients treated with PD-1 and PD-L1 inhibitors, the objective response rate was 29%, with a median overall survival of 10 months and median progression-free survival of 5 months, indicating these treatments are effective in a real-world setting.

The implementation of a standardized management protocol, including assessments by internal medicine specialists, improved the resolution of immune-related adverse events, highlighting the importance of proactive management in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach. Grimaud, F., Penaranda, G., Stavris, C., et al.[2022]

In a study of 10 patients with advanced non-small cell lung cancer (NSCLC), the combination of sintilimab immunotherapy with bronchial arterial infusion chemotherapy resulted in an impressive objective response rate of 80% and a complete disease control rate of 100%.

The treatment was found to be safe, with only two cases of Grade III adverse events reported, and it showed promising median progression-free survival of 11 months and overall survival of 8 months, suggesting that adding immunotherapy may enhance outcomes compared to previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sintilimab plus Bronchial Arterial Infusion Chemotherapy/Drug-Eluting Embolic Chemoembolization for Advanced Non-Small Cell Lung Cancer: A Preliminary Study of 10 Patients. Li, YM., Guo, RQ., Bie, ZX., et al.[2022]

In a study involving 39 children with refractory solid tumors, the combination of cixutumumab and temsirolimus was found to have a maximum tolerated dose (MTD) of 6 mg/kg and 8 mg/m², with mucositis being the most common dose-limiting toxicity.

The treatment effectively inhibited mTOR signaling pathways, as evidenced by decreased levels of S6K1 and PAkt in blood cells, indicating a biological response to the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase I Study of Cixutumumab (IMC-A12) in Combination with Temsirolimus (CCI-779) in Children with Recurrent Solid Tumors: A Children's Oncology Group Phase I Consortium Report. Fouladi, M., Perentesis, JP., Wagner, LM., et al.[2019]

In a study involving 1,453 patients with advanced melanoma and non-small cell lung cancer (NSCLC), pembrolizumab showed no dependency on dosage for overall survival, indicating that varying doses (2 to 10 mg/kg) did not significantly affect patient outcomes.

A strong association was found between the baseline clearance (CL0) of pembrolizumab and overall survival, suggesting that higher clearance rates may indicate more severe disease, rather than affecting the drug's efficacy directly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab Exposure-Response Assessments Challenged by Association of Cancer Cachexia and Catabolic Clearance. Turner, DC., Kondic, AG., Anderson, KM., et al.[2019]

Pembrolizumab was found to be safe and well tolerated in a phase I study involving 20 patients with advanced solid tumors, with no dose-limiting toxicities observed at doses up to 10 mg/kg every 2 weeks.

The treatment demonstrated durable antitumor activity, with complete responses in two patients and stable disease in 15 others, indicating that a minimum effective dose for antitumor activity is 2 mg/kg every 3 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Study of Pembrolizumab (MK-3475; Anti-PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors. Patnaik, A., Kang, SP., Rasco, D., et al.[2022]

In a study of 88 advanced melanoma patients treated with pembrolizumab, 81.8% experienced any-grade toxicities, with skin and gastrointestinal issues being the most common side effects.

Despite the high incidence of side effects, pembrolizumab was found to be well tolerated in real-world settings, and severe toxicities were manageable with systemic steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. So, AC., Board, RE.[2022]

Cetrelimab, a PD-1 inhibitor, was found to have a manageable safety profile in patients with advanced solid tumors, with 53.9% experiencing grade ≥3 adverse events, and 35.3% having immune-related adverse events.

In terms of efficacy, cetrelimab showed an overall response rate of 18.6% across various tumor types, with higher rates in specific cancers like non-small-cell lung cancer (34.3%) and melanoma (28.0%), indicating its potential as a treatment option for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers. Felip, E., Moreno, V., Morgensztern, D., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06438263

A Study to Evaluate Bioavailability of Rocatinlimab ... The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to ...

2. prnewswire.com prnewswire.com/news-releases/kyowa-kirin-announces-top-line-data-from-rocatinlimab-phase-3-rocket-horizon-trial-for-adults-with-moderate-to-severe-atopic-dermatitis-302258420.html

Kyowa Kirin Announces Top-line Data from Rocatinlimab ... The trial includes 726 adult patients who were randomized to receive rocatinlimab or placebo administered through a subcutaneous injection every ...

3. kyowakirin.com kyowakirin.com/media_center/news_releases/2022/pdf/e20221213_01.pdf

Kyowa Kirin Announces Lancet Publication of Phase 2b ... The Phase 2b multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of rocatinlimab in adults with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06224192

NCT06224192 | A Study With Self-administered ... The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection. Official Title. A ...

5. amgentrials.com amgentrials.com/study/?id=20230180

A Study With Self-administered Rocatinlimab in Adolescent ... The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.

6. amgentrials.com amgentrials.com/study/?id=20220014

A Study to Evaluate Bioavailability of Rocatinlimab ... The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to ...