What Is Nemolizumab?
Nemolizumab is an investigational drug currently being studied in clinical trials for various conditions, primarily those involving skin inflammation and severe itching. It is administered as a subcutaneous injection, meaning it is injected under the skin. Some studies are exploring its use with an auto-injector or a dual chamber syringe for convenient administration. The provided trial descriptions do not detail Nemolizumab's specific mechanism of action. Instead, they focus on its method of delivery and the conditions it aims to treat.
Nemolizumab has been investigated in 22 clinical trials to date, with 4 trials currently recruiting participants and 14 trials completed. These studies have involved a total of 6,384 participants. The first trial for Nemolizumab began in 2013, and the latest trial is projected to conclude in 2026. It is being studied for conditions such as atopic dermatitis, prurigo nodularis, and chronic pruritus.
Uses and Conditions Under Study
Nemolizumab is being investigated across a range of conditions, primarily focusing on inflammatory skin disorders and chronic itching. Clinical trials are exploring its potential benefits in the following areas:
- Atopic Dermatitis: This chronic inflammatory skin condition, also known as eczema, causes dry, itchy, and inflamed skin. Nemolizumab is being studied for atopic dermatitis, including moderate-to-severe forms, across 12 clinical trials. The goal is to assess its effectiveness in managing the symptoms of this common skin disorder.
- Pruritic Conditions: Nemolizumab is also under investigation for conditions characterized by severe itching (pruritus). This includes Prurigo Nodularis, a skin disease causing intensely itchy, firm lumps, and Chronic Pruritus of Unknown Origin. Additionally, it is being studied for Chronic Kidney Disease Associated Moderate to Severe Pruritus. In total, 6 trials are dedicated to these pruritic conditions.
- Systemic Sclerosis: This is a rare, chronic autoimmune disease that causes hardening and tightening of the skin and connective tissues. Nemolizumab is being explored in 2 trials for its potential role in managing symptoms of systemic sclerosis.
- Psoriasis: Another chronic autoimmune condition, psoriasis causes skin cells to build up rapidly on the surface of the skin, forming thick, silvery scales and itchy, dry, red patches. Nemolizumab is being studied in 2 trials for psoriasis.
- Lichen Plano-Pilaris (LPP): LPP is a rare inflammatory condition that affects hair follicles, leading to progressive, permanent hair loss and scalp symptoms like itching and burning. Nemolizumab is being investigated in 1 trial for LPP, where current treatments are often inadequate.
These studies aim to determine the safety and efficacy of Nemolizumab in addressing the unmet medical needs of patients with these challenging conditions.
Dosing
Nemolizumab is administered as a subcutaneous injection. Clinical trials have explored different methods of administration, including standard subcutaneous injections, administration via an auto-injector (AI), and using a dual chamber syringe (DCS).
Various doses and regimens have been studied. Some trials involve a loading dose, such as 60 milligrams (mg) (given as two 30 mg injections) at the start of treatment. Following the loading dose, a common regimen involves administering 30 mg of nemolizumab via a single subcutaneous injection once every four weeks (Q4W) for a specified period, such as up to week 12. Other studies have investigated different strengths, including 30 mg and 60 mg doses, and some regimens are based on patient weight.
In addition to adult dosing, Nemolizumab is also being investigated in pediatric populations. Specific cohorts in trials have included participants aged 7-11 years and younger participants aged 2-6 years. These studies aim to determine appropriate and safe dosing for children in different age groups.
Other investigational forms or combinations include "Nemolizumab Dose 1," "Nemolizumab Dose 2," "CYP 450 Substrates plus Nemolizumab," and various "Group" designations (e.g., Group 1, Group 2, Group 3, Group 4, Group 5) which likely represent different dosing arms or treatment combinations within a study.
Side Effects
In clinical trials, the most common side effect reported by patients taking Nemolizumab was atopic dermatitis. 11.9% of patients taking Nemolizumab experienced atopic dermatitis, compared to 9.0% on placebo. Other common side effects included:
- Nasopharyngitis (common cold symptoms): 7.5% of patients on Nemolizumab experienced this, compared to 5.6% on placebo.
- Headache: 6.0% of patients on Nemolizumab experienced this, compared to 3.2% on placebo.
- Neurodermatitis: 5.7% of patients on Nemolizumab experienced this, compared to 14.4% on placebo.
- Increased blood creatine phosphokinase: 5.5% of patients on Nemolizumab experienced this, compared to 3.6% on placebo.
- Peripheral swelling (oedema peripheral): 4.4% of patients on Nemolizumab experienced this, compared to 1.4% on placebo.
- Asthma: 4.4% of patients on Nemolizumab experienced this, compared to 3.8% on placebo.
- Impetigo (a skin infection): 3.8% of patients on Nemolizumab experienced this, compared to 0.0% on placebo.
Clinical Trial Results
Nemolizumab for Atopic Dermatitis
In a Phase 2 study (NCT01986933) involving patients with atopic dermatitis, Nemolizumab showed improvements in skin condition and itch. At Week 12, patients receiving Nemolizumab 0.5 mg/kg every four weeks experienced a 61.24% reduction in pruritus (itch) severity as measured by the Visual Analogue Scale (VAS), compared to a 20.07% reduction in the placebo group. The Eczema Area and Severity Index (EASI) score, which measures the extent and severity of eczema, improved by an average of 42.16% with Nemolizumab 0.5 mg/kg every four weeks, compared to an 18.27% improvement with placebo.
Another dose-ranging study (NCT03100344) further assessed Nemolizumab in atopic dermatitis patients. At Week 24, patients on Nemolizumab 30 mg experienced a 73.4% average reduction in EASI score from baseline, compared to a 58.4% reduction with placebo. The SCORing Atopic Dermatitis (SCORAD) score also improved by an average of 62.5% in the 30 mg Nemolizumab group, versus 42.6% with placebo. Additionally, sleep disturbance, measured by the Numeric Rating Scale (NRS), improved by an average of 76.2% in the 30 mg Nemolizumab group, compared to a 50.7% improvement with placebo.
A study specifically for adolescents with atopic dermatitis (NCT03921411) demonstrated that Nemolizumab led to a 66.52% average reduction in EASI score at Week 16. Average pruritus NRS scores improved by 40.85%, and sleep disturbance NRS scores improved by 53.51% from baseline. Quality of life, as measured by the Dermatology Life Quality Index (DLQI) for participants over 16 years, improved from an average of 11.8 at baseline to 3.0 at Week 16, indicating a significant positive impact.
Two larger studies (NCT03985943 and NCT03989349) evaluated Nemolizumab 30 mg in patients with moderate-to-severe atopic dermatitis. At Week 16, across both studies, approximately 28-31% of patients treated with Nemolizumab achieved a weekly average peak pruritus NRS score of less than 2 points (indicating minimal to no itch), compared to 11-12% of patients on placebo. Furthermore, 42-44% of Nemolizumab-treated patients achieved at least a 75% improvement in EASI score (EASI-75), compared to 29-30% on placebo. Improvements in sleep disturbance (a reduction of 4 points or more on the SD NRS) were seen in 34-38% of Nemolizumab patients, versus 16-20% on placebo.
Currently Recruiting Trials
Nemolizumab is currently being investigated in several clinical trials for various conditions, offering opportunities for patients to contribute to medical research. These studies aim to evaluate the safety and effectiveness of Nemolizumab, an investigational treatment designed to address a range of inflammatory and pruritic (itchy) skin conditions. One ongoing Phase 2 study, sponsored by Galderma R&D, is evaluating Nemolizumab for the treatment of adults with Systemic Sclerosis. This trial, NCT07047690, plans to enroll 162 participants. Its primary goal is to assess Nemolizumab's impact on skin thickness and its overall safety over a 52-week treatment period, helping to determine the most effective dose for this patient population. Another study, NCT07396168, is a Phase 4 pilot study exploring Nemolizumab as a treatment for Lichen Planopilaris (LPP). Sponsored by The Skin Center Dermatology Group, this trial aims to enroll 10 participants. LPP is a condition characterized by progressive, permanent hair loss and uncomfortable scalp symptoms like itching and burning. This study investigates Nemolizumab's potential to address these challenging symptoms. Galderma R&D is also sponsoring a Phase 2 proof-of-concept study, NCT07074977, focusing on Chronic Pruritus of Unknown Origin (CPUO). This trial plans to enroll 50 adult participants aged 18 years or above. The main objective is to understand the relationship between Nemolizumab's pharmacokinetics (how the body affects the drug) and pharmacodynamics (how the drug affects the body) over a 16-week treatment period. Additionally, a pilot project titled "Molecular Signatures in Inflammatory Skin Disease," NCT03358693, is recruiting 300 participants. Sponsored by Prof. Dr. Stephan Weidinger, this study aims to use a systems medicine approach to identify regulatory networks in conditions like Atopic Dermatitis and Psoriasis. It seeks to gain a comprehensive understanding of disease mechanisms and control, contributing to the broader research landscape that includes Nemolizumab.Where to Participate
Clinical trials for Nemolizumab are being conducted across a wide geographic area, with study sites located in 14 states across the United States. In total, there are 21 sites in 19 cities actively seeking participants. Some of the top locations with Nemolizumab study sites include:- New City, New York (2 sites)
- Ann Arbor, Michigan (2 sites)
- Sacramento, California (1 site)
- San Diego, California (1 site)
- San Francisco, California (1 site)
- Miami, Florida (1 site)
- Tampa, Florida (1 site)
- Indianapolis, Indiana (1 site)
- Saint Joseph, Missouri (1 site)
- Las Vegas, Nevada (1 site)