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Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)
Phase 3 trial testing Lebrikizumab in Atopic Dermatitis in 1,153 participants. Completed in 22 April 2025.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 1,153 |
| Start date | 15 June 2020 |
| Primary completion | 19 July 2024 |
| Estimated completion | 22 April 2025 |
| Sites | 321 locations across France, Ukraine, Taiwan, Estonia, Germany, Poland, Mexico, South Korea |
Eli Lilly and Company — full company profile →
12 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of participants discontinued from study treatment due to adverse events is reported.
| Group | Value | 95% CI |
|---|---|---|
| Primary Treatment Period: Lebrikizumab Q4W | 2.1 | |
| Primary Treatment Period: Lebrikizumab Q2W | 4.5 |
The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point.
| Group | Value | 95% CI |
|---|---|---|
| Primary Treatment Period: Lebrikizumab Q4W | 80.1 | |
| Primary Treatment Period: Lebrikizumab Q2W | 60.6 |
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these
| Group | Value | 95% CI |
|---|---|---|
| Primary Treatment Period: Lebrikizumab Q4W | 90.4 | |
| Primary Treatment Period: Lebrikizumab Q2W | 79.4 |
Time frame: Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Primary Treatment Period: … | Primary Treatment Period: … | Open-Label Extension Adden… | Open-Label Extension Adden… |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Ankle fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Hip fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Depression suicidal | Psychiatric disorders | — | — | — | — |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Cardiac failure | Cardiac disorders | — | — | — | — |
| Cataract | Eye disorders | — | — | — | — |
| Sudden visual loss | Eye disorders | — | — | — | — |
| Hiatus hernia | Gastrointestinal disorders | — | — | — | — |
| Large intestine polyp | Gastrointestinal disorders | — | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — | — |
| Death | General disorders | — | — | — | — |
| Influenza like illness | General disorders | — | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — | — |
| Anaphylactic shock | Immune system disorders | — | — | — | — |
| Food allergy | Immune system disorders | — | — | — | — |
| Bacteraemia | Infections and infestations | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — |
| Covid-19 | Infections and infestations | — | — | — | — |
| Subcutaneous abscess | Infections and infestations | — | — | — | — |
| Vulval abscess | Infections and infestations | — | — | — | — |
| Accident | Injury, poisoning and procedural complications | — | — | — | — |
| Reaction | System | Primary Treatment Period: … | Primary Treatment Period: … | Open-Label Extension Adden… | Open-Label Extension Adden… |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Conjunctivitis | Infections and infestations | — | — | — | — |
| Oral herpes | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Conjunctivitis allergic | Eye disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Acne | Skin and subcutaneous tissue disorders | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — | — |
| Injection site reaction | General disorders | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — |
| Folliculitis | Infections and infestations | — | — | — | — |
| Herpes zoster | Infections and infestations | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — | — | — |
| Eosinophilia | Blood and lymphatic system disorders | — | — | — | — |
| Herpes simplex | Infections and infestations | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — |
| Iron deficiency anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Seasonal allergy | Immune system disorders | — | — | — | — |
| Vaccination site pain | General disorders | — | — | — | — |
| Impetigo | Infections and infestations | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Hepatic steatosis | Hepatobiliary disorders | — | — | — | — |
| Ligament sprain | Injury, poisoning and procedural complications | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — | — | — |
Most-reported serious reactions: Appendicitis, Pneumonia, Ankle fracture, Hip fracture, Prostate cancer, Depression suicidal, Dermatitis atopic, Atrial fibrillation.
Data from ClinicalTrials.gov NCT04392154 adverse events section.
This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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/NCT04392154.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing