All > Seborrheic Dermatitis > Atopic Dermatitis

Rocatinlimab for Atopic Dermatitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Clarity Dermatology, Castle Rock, COAtopic DermatitisRocatinlimab - Drug
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

Study Summary

This trial compares a new drug to placebo to see if it helps reduce eczema symptoms.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Zabedosertib
1
ASLAN004
1
ADX-914

Study Objectives

2 Primary · 25 Secondary · Reporting Duration: Baseline to Week 24

Baseline and Week 16
Achievement of EASI 75 at Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Achievement of vIGA-AD 0/1 at Week 16
Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Change from Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Baseline and Week 24
Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score >/=8
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score >/=8
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
Achievement of a Genital AD Severity Score of Clear at Week 24 for Participants with Genital AD at Baseline
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a >= 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score ≥ 4
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Achievement of a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI ≥ 4
Achievement of a ≥ 8.7-point Reduction from Baseline in Severity Scoring of Atopic Dermatitis (SCORAD) Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7
Achievement of vIGA-AD 0/1 and Presence of Barely Perceptible Erythema or No Erythema at Week 24
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Change from Baseline in DLQI Score at Week 24
Change from Baseline in HADS-anxiety Subscale Score at Week 24
Change from Baseline in HADS-depression Subscale Score at Week 24
Change from Baseline in POEM Score at Week 24
Change from Baseline in SCORAD Itch VAS Score at Week 24
Change from Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Baseline to Week 16
Change from Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Baseline to Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Zabedosertib
2
ASLAN004
2
ADX-914

Side Effects for

KHK4083 Cohort 4
14%Anaemia
10%Colitis ulcerative
5%Chills
5%Pyrexia
5%Pneumonia
5%Lymphopenia
5%Pharyngitis
5%Urinary tract infection
5%Blood creatine phosphokinase increased
5%Arthralgia
5%Blood albumin decreased
5%Post procedural infection
5%Clostridium difficile infection
5%Sinusitis
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02647866) in the KHK4083 Cohort 4 ARM group. Side effects include: Anaemia with 14%, Colitis ulcerative with 10%, Chills with 5%, Pyrexia with 5%, Pneumonia with 5%.

Trial Design

2 Treatment Groups

Rocatinlimab
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

680 Total Participants · 2 Treatment Groups

Primary Treatment: Rocatinlimab · Has Placebo Group · Phase 3

Rocatinlimab
Drug
Experimental Group · 1 Intervention: Rocatinlimab · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 24

Who is running the clinical trial?

AmgenLead Sponsor
1,301 Previous Clinical Trials
1,329,584 Total Patients Enrolled
MDStudy DirectorAmgen
843 Previous Clinical Trials
898,783 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old and have been diagnosed with AD for at least 6 months based on AAD Consensus Criteria from 2014.
You experience severe itching, rated 4 or higher on a scale.
References

Frequently Asked Questions

Are seniors over the age of 85 able to partake in this experimentation?

"As specified by the clinical trial's inclusion criteria, only patients aged 18-100 are eligible. Separately, 102 trials and 168 trials have been created for individuals younger than 18 and over 65 respectively." - Anonymous Online Contributor

Unverified Answer

Has enrollment for this therapeutic trial been opened up?

"Correct. The information posted on clinicaltrials.gov affirms that this medical trial, first published on December 14th 2022, is still recruiting patients. Approximately 680 individuals need to be enrolled from 6 differing locations." - Anonymous Online Contributor

Unverified Answer

Has Rocatinlimab been endorsed by the FDA?

"Rocatinlimab has been assessed with a rating of 3 due to the presence of data evidencing its efficacy and multiple iterations of safety-related research." - Anonymous Online Contributor

Unverified Answer

Are there numerous facilities offering this trial in the North American region?

"Patients wishing to take part in this clinical trial can enrol at Clinical Science Institute (Santa Monica, California), St. Jude Clinical Research (Doral, Florida) and Kentucky Advanced Medical Research LLC (Murray, Kentucky). There are 6 other additional sites taking patients as well." - Anonymous Online Contributor

Unverified Answer

What is the aggregate amount of participants enrolled in this trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively seeking individuals for its study; it was initially announced on December 14th 2022 and underwent a recent alteration on the 16th of that same month. 680 participants are needed from 6 distinct locations." - Anonymous Online Contributor

Unverified Answer

Do I meet the prerequisites to partake in this medical experiment?

"This trial requires 680 adults (18 and above) with a 6-month history of dermatitis that has proven ineffective to mid or higher potency topical corticosteroids, as well as an EASI score ≥16, vIGA-AD score≥3, worst pruritus numerical rating scale ≥4, and BSA involvement of at least 10%." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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