Rocatinlimab for Atopic Dermatitis

(ROCKET-VOYAGER Trial)

Recruiting at 92 trial locations

Overseen By Amgen Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Biologics, Corticosteroids, Immunosuppressants, others

Disqualifiers: Live vaccines, Meningococcal vaccine, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

221 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called rocatinlimab to see if it changes how well people respond to tetanus and meningococcal vaccines by measuring antibody levels.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications before joining the trial. There are specific timeframes for stopping different types of medications, such as biologics, systemic corticosteroids, and topical treatments, before starting the trial.

What data supports the effectiveness of the drug rocatinlimab for atopic dermatitis?

Research shows that rocatinlimab, an anti-OX40 antibody, led to a significant reduction in symptoms of atopic dermatitis compared to a placebo, with improvements in skin condition observed in a clinical trial. ^{1 2 3 4 5}

Is rocatinlimab safe for humans?

Rocatinlimab, also known as KHK4083 or AMG-451, was tested in a study for people with moderate-to-severe atopic dermatitis and showed a good safety profile, meaning it was generally safe for use in humans. ^{1 3 4 5 6}

What makes the drug rocatinlimab unique for treating atopic dermatitis?

Rocatinlimab is unique because it targets the OX40-OX40L pathway, which is important for T-cell responses involved in atopic dermatitis, offering a novel approach compared to other treatments that focus on different immune pathways. ^{1 3 4 5 7}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

Adults aged 18-54 with moderate-to-severe atopic dermatitis (AD) for at least a year, who haven't responded well to strong topical corticosteroids or other treatments. Participants should not have used biologics recently, nor received certain vaccines or immunosuppressive therapies within specific time frames before the trial.

Inclusion Criteria

I've had systemic treatment for AD but still qualify after a proper washout period.

Your skin condition, as assessed by the doctor, is rated as moderate or severe.

I am between 18 and 54 years old and have been diagnosed with atopic dermatitis for at least a year.

Exclusion Criteria

I haven't used any strong skin medications or treatments in the last week.

I haven't had meningococcal or tetanus/diphtheria/pertussis vaccines recently.

I have not received any live virus vaccines in the last 12 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rocatinlimab or placebo every 4 weeks for 24 weeks with a loading dose at Week 2

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Rocatinlimab

Trial Overview The study is testing Rocatinlimab against a placebo to see if it affects how the body responds to tetanus and meningococcal vaccines. The effectiveness will be measured by comparing antibody responses in both groups after 24 weeks.

Participant Groups

Group I: Rocatinlimab Experimental Treatment 1 Intervention

Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Group II: Placebo Placebo Group 1 Intervention

Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

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

Findings from Research

Ruxolitinib cream showed effective long-term disease control in atopic dermatitis, with 74.1% to 77.8% of patients achieving low disease severity scores after 52 weeks of treatment.

The cream was well-tolerated, with most adverse events being mild and unrelated to the treatment, suggesting a favorable safety profile and minimal systemic absorption of the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. Papp, K., Szepietowski, JC., Kircik, L., et al.[2023]

In a phase 2b study involving 274 adults with moderate-to-severe atopic dermatitis, rocatinlimab significantly reduced Eczema Area and Severity Index (EASI) scores compared to placebo, with reductions of up to 61.1% observed at week 16 for the highest dose.

Rocatinlimab was generally well tolerated, with common side effects including pyrexia and nasopharyngitis, but no deaths were reported, indicating a favorable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. Guttman-Yassky, E., Simpson, EL., Reich, K., et al.[2023]

Rocatinlimab and amlitelimab, two inhibitors targeting the OX40-OX40L pathway, showed significant efficacy in reducing atopic dermatitis symptoms in clinical trials, with rocatinlimab achieving a reduction of 48.3% to 61.1% in the EASI score compared to a placebo reduction of 15.0%.

Both treatments were found to be safe and well tolerated, with amlitelimab demonstrating a mean percentage change of 69.9% to 80.1% in EASI scores at week 16, indicating their potential as effective disease-modifying therapies for moderate-to-severe atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab. Lé, AM., Torres, T.[2023]

Abrocitinib, an oral Janus kinase 1 inhibitor, provided significant itch relief in patients with moderate-to-severe atopic dermatitis as early as day 4, outperforming both dupilumab and placebo in a phase III trial with adult patients.

Early improvement in itch relief (measured by the Peak Pruritus Numerical Rating Scale) at week 2 was predictive of better overall skin clearance and severity outcomes at week 12 for patients treated with abrocitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial. Ständer, S., Kwatra, SG., Silverberg, JI., et al.[2023]

Abrocitinib, a JAK1-selective inhibitor, has been shown to have a manageable long-term safety profile for treating moderate-to-severe atopic dermatitis, based on an analysis of 2856 patients over 1614 patient-years.

While some dose-related adverse events like nausea and headache were observed, serious infections and other severe complications were relatively low, indicating that with proper patient selection, abrocitinib can be safely used for extended periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Simpson, EL., Silverberg, JI., Nosbaum, A., et al.[2022]

Topical treatments like corticosteroids and calcineurin inhibitors, along with systemic options such as Janus kinase inhibitors and interleukin inhibitors, have shown significant efficacy in treating moderate-to-severe atopic dermatitis (AD).

The review compiles pivotal clinical trial data and real-world experiences to assess the safety and efficacy of these treatments, helping to guide optimal therapy choices for patients with AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated Review on Treatment of Atopic Dermatitis. Armario-Hita, JC., Galán-Gutiérrez, M., Dodero-Anillo, JM., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). [2023]

3. England pubmed.ncbi.nlm.nih.gov

An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Updated Review on Treatment of Atopic Dermatitis. [2023]