NCT04791319 (GENESIS) is a Phase 2 clinical trial of Bermekimab in Dermatitis, Atopic, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT04791319?

NCT04791319 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT04791319?

Interventions in NCT04791319: Placebo, Bermekimab, Dupilumab.

What condition does NCT04791319 study?

NCT04791319 studies Dermatitis, Atopic.

Is NCT04791319 still recruiting?

NCT04791319 is currently terminated. Last updated 1 March 2023.

Are results published for NCT04791319?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-01 · How we verify

NCT04791319: GENESIS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis

Terminated Phase 2 Results posted Last updated 1 March 2023

What this trial tests

Phase 2 trial testing Placebo in Dermatitis, Atopic in 199 participants. Terminated before completion.

Timeline

3 May 2021

Primary endpoint
2 February 2022

31 March 2022

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	199
Start date	3 May 2021
Primary completion	2 February 2022
Estimated completion	31 March 2022
Sites	42 locations across Japan, Germany, Poland, Canada, United States

Drugs / interventions tested

Placebo
Bermekimab — full drug profile →
Dupilumab (DUPILUMAB) — full drug profile →

Conditions studied

Dermatitis, Atopic — all drugs for Dermatitis, Atopic →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Dermatitis, Atopic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline) at Week 16 Primary · Week 16

Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Group	Value	95% CI
Placebo	9.5
Bermekimab 350 mg	16.7
Bermekimab 700 mg	16.7
Dupilumab	51.2

Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16 Secondary · Week 16

Percentage of participants achieving vIGA-AD at Week 16 were reported. It is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0, where 0=Clear: No inflammatory signs of AD; 1=almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2=mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3=moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present and 4=severe: Marked erythema, i

Group	Value	95% CI
Placebo	9.5
Bermekimab 350 mg	12.5
Bermekimab 700 mg	11.9
Dupilumab	27.9

Percentage of Participants With Improvement (Reduction From Baseline) in Eczema-Related Itch Numeric Rating Scale (NRS) of Score >=4 at Week 16 Among Participants With a Baseline Itch Value >=4 Secondary · Week 16

Percentage of participants with improvement (reduction from baseline) in eczema-related itch NRS of score \>=4 at Week 16 among participants with a baseline itch value \>=4 were reported. The eczema skin pain and Itch NRS is a 2-item patient-reported outcome that participants used to rate the severity of their eczema-related skin pain and eczema related itch daily. Participants were asked the following questions: Please rate the severity of your eczema-related skin pain at its worst in the past 24 hours; and please rate the severity of your eczema-related itch at its worst in the past 24 hours

Group	Value	95% CI
Placebo	10.5
Bermekimab 350 mg	20.0
Bermekimab 700 mg	6.3
Dupilumab	32.4

Percentage of Participants Achieving EASI-90 (>= 90% Improvement in EASI From Baseline) at Week 16 Secondary · Week 16

Percentage of participants achieving EASI-90 at Week 16 were reported. EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Group	Value	95% CI
Placebo	9.5
Bermekimab 350 mg	12.5
Bermekimab 700 mg	11.9
Dupilumab	34.9

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Secondary · Up to Week 36

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were AEs with onset during the intervention period or that were a consequence of a pre-existing condition that has worsened since baseline. AEs are presented by individual dose received by participants during placebo-controlled period and by responders individual dose received during active treatment period.

Group	Value	95% CI
Placebo	18
Bermekimab 350 mg	26
Bermekimab 700 mg	46
Dupilumab	40
Placebo Then Bermekimab 700 mg	7
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	2
Dupilumab Then Bermekimab 700 mg (Non-Responders)	4

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Secondary · Up to Week 36

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed abo

Group	Value	95% CI
Placebo	0
Bermekimab 350 mg	1
Bermekimab 700 mg	2
Dupilumab	0
Placebo Then Bermekimab 700 mg	0
Bermekimab 350 mg Then Bermekimab 350 mg	0
Bermekimab 700 mg Then Bermekimab 700 mg (Non-Responders)	0
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	0
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	0
Dupilumab Then Dupilumab 300 mg (Responders)	0
Dupilumab Then Bermekimab 700 mg (Non-Responders)	0

Serum Bermekimab Concentration Over Time Secondary · Pre-dose at Week 0, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, and Week 36

Serum bermekimab concentration over time were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.

Week 0

Group	Value	95% CI
Bermekimab 350 mg	0.00	± 0.000
Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)	0.00	± 0.000
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	0.00	± 0.000
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	0.00	± 0.000

Week 1

Group	Value	95% CI
Bermekimab 350 mg	24.80	± 10.156
Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)	44.61	± 16.945
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	36.88	± 2.831
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	34.96	± 11.796

Week 4

Group	Value	95% CI
Bermekimab 350 mg	37.85	± 19.347
Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)	75.65	± 35.815
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	83.07	± 46.927
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	71.15	± 29.254

Week 8

Group	Value	95% CI
Bermekimab 350 mg	42.33	± 20.880
Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)	81.25	± 41.734
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	80.72	± 40.377
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	76.88	± 32.047

Week 12

Group	Value	95% CI
Bermekimab 350 mg	46.90	± 19.759
Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)	81.17	± 42.878
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	83.89	± 21.875
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	74.06	± 32.283

Week 16

Group	Value	95% CI
Placebo Then Bermekimab 700 mg	0.00	± 0.000
Bermekimab 350 mg	51.26	± 19.349
Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)	80.56	± 46.644
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	83.35	± 43.518
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	77.95	± 47.186

Week 20

Group	Value	95% CI
Placebo Then Bermekimab 700 mg	86.49	± 43.182
Bermekimab 350 mg	50.91	± 20.004
Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)	79.51	± 50.180
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	82.14	± 21.151
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	38.73	± 19.023

Week 24

Group	Value	95% CI
Placebo Then Bermekimab 700 mg	90.40	± 51.619
Bermekimab 350 mg	55.55	± 24.609
Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)	65.57	± 31.614
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	45.13	± 31.291
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	23.93	± 17.506

Number of Participants With Anti-Bermekimab Antibodies Secondary · Up to Week 36

Number of participants with anti-bermekimab antibodies were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.

Group	Value	95% CI
Placebo Then Bermekimab 700 mg	1
Bermekimab 350 mg	9
Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)	2
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	0
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/33 (0%)

Deaths: 0/33

Bermekimab 350 mg

Serious: 1/33 (3%)

Deaths: 0/33

Bermekimab 700 mg

Serious: 2/67 (3%)

Deaths: 0/67

Dupilumab

Serious: 0/65 (0%)

Deaths: 0/65

Placebo Then Bermekimab 700 mg

Serious: 0/19 (0%)

Deaths: 0/19

Bermekimab 350 mg Then Bermekimab 350 mg

Serious: 0/21 (0%)

Deaths: 0/21

Bermekimab 700 mg Then Bermekimab 700 mg (Non-Responders)

Serious: 0/22 (0%)

Deaths: 0/22

Bermekimab 700 mg Then Bermekimab 700 mg (Responders)

Serious: 0/3 (0%)

Deaths: 0/3

Bermekimab 700 mg Then Bermekimab 350 mg (Responders)

Serious: 0/5 (0%)

Deaths: 0/5

Dupilumab Then Dupilumab 300 mg (Responders)

Serious: 0/27 (0%)

Deaths: 0/27

Dupilumab Then Bermekimab 700 mg (Non-Responders)

Serious: 0/11 (0%)

Deaths: 0/11

Serious adverse events (3 terms)

Reaction	System	Placebo	Bermekimab 350 mg	Bermekimab 700 mg	Dupilumab	Placebo Then Bermekimab 70…	Bermekimab 350 mg Then Ber…	Bermekimab 700 mg Then Ber…	Bermekimab 700 mg Then Ber…	Bermekimab 700 mg Then Ber…	Dupilumab Then Dupilumab 3…	Dupilumab Then Bermekimab …
Auricular Haematoma	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Dermatitis Atopic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (30 terms — click to expand)

Reaction	System	Placebo	Bermekimab 350 mg	Bermekimab 700 mg	Dupilumab	Placebo Then Bermekimab 70…	Bermekimab 350 mg Then Ber…	Bermekimab 700 mg Then Ber…	Bermekimab 700 mg Then Ber…	Bermekimab 700 mg Then Ber…	Dupilumab Then Dupilumab 3…	Dupilumab Then Bermekimab …
Dermatitis Atopic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Injection Site Erythema	General disorders	—	—	—	—	—	—	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Injection Site Swelling	General disorders	—	—	—	—	—	—	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Oral Herpes	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Extrasystoles	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Dry Eye	Eye disorders	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Chest Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—
Eczema Impetiginous	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis Viral	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Impetigo	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Lice Infestation	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Pilonidal Cyst	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Ligament Sprain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Vaccination Complication	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Blood Pressure Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Auricular Haematoma, Aspartate Aminotransferase Increased, Dermatitis Atopic.

Data from ClinicalTrials.gov NCT04791319 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of bermekimab in participants with moderate to severe atopic dermatitis (AD).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

A Systematic Review of Atopic Dermatitis: The Intriguing Journey Starting from Physiopathology to Treatment, from Laboratory Bench to Bedside.
Radi G, Campanti A, Diotallevi F, Martina E, et al · · 2022 · cited 17× · PMID 36359220 · DOI 10.3390/biomedicines10112700
A new era has begun: Treatment of atopic dermatitis with biologics.
Stölzl D, Weidinger S, Drerup K. · · 2021 · cited 12× · PMID 34532635 · DOI 10.5414/alx02259e
Interleukin-1α inhibitor bermekimab in patients with atopic dermatitis: randomized and nonrandomized studies.
Simpson EL, Guttman-Yassky E, Pawlikowski J, Ghorayeb EG, et al · · 2024 · cited 8× · PMID 39214920 · DOI 10.1007/s00403-024-03319-z
A Model-Based Meta-Analysis Framework Quantifying Drivers of Placebo Response in Atopic Dermatitis Trials.
Serrano JC, Maringwa J, Straetemans R, Willems W, et al · · 2026 · cited 1× · PMID 41247234 · DOI 10.1002/psp4.70150

Verify or expand the search:

Other trials of Bermekimab

Trials testing the same drug.

NCT04988308 — A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa · Phase 2 · terminated
NCT04990440 — A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis · Phase 2 · terminated

Other recruiting trials for Dermatitis, Atopic

Currently open trials in the same condition.

NCT07230860 — A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis · Phase 2 · recruiting
NCT06899204 — Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate · recruiting
NCT07042126 — Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis · Phase 3 · recruiting
NCT06881251 — A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD) · Phase 2 · active not recruiting
NCT06554847 — Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis · Phase 3 · active not recruiting

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
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NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04791319 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 1 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04791319.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing