A Phase 1/2 interventional study of CC-10004 in Discoid Lupus Erythematosus, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by NYU Langone Health · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.
Discoid cutaneous lupus is the most common cutaneous manifestation of lupus erythematosus, a chronic, immune mediated disease of unknown etiology. The immune processes underlying cutaneous lupus remain largely unexplored, but recent evidence suggests a role for dendritic cells (DCs), type 1 interferons (IFN) and Th1-type immune processes. Treatment of cutaneous lupus remains limited primarily to anti-malarials, with thalidomide an effective secondary agent. However, side effects associated with these treatments are potentially problematic with chronic use. Phosphodiesterases (PDE) are critical enzymes that degrade cAMP. In particular, PDE type 4 (PDE4) activity is found in inflammatory and immune cells, including DCs. The immune modulator CC-10004 is a PDE4 inhibitor with demonstrated low toxicity in phase I and II clinical studies with potential efficacy in cutaneous lupus. CC-10004 is a well-tolerated, selective PDE4 inhibitor with demonstrated inhibitory effects on Th1-type cytokines and other inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions. Prior studies include pilot trials in psoriasis and exercise-induced asthma, with results suggesting clinical efficacy in the former study. This open label, pilot study of 16 weeks duration will explore the clinical and immune-modulating effects of CC-10004 in 10 cutaneous discoid lupus patients. Patients meeting study criteria will receive the drug for 12 weeks, followed by a 4-week washout period. Study visit time points will include weeks 0, 1, 2, 4, 6, 8, 10, 12 and 16, during which we will measure outcomes for clinical, immunological and safety parameters. To investigate early immunological changes occurring in response to treatment, we will also perform skin punch biopsies of lesional sites at week 0 and week 4 for immunohistochemical and molecular analysis.
40 studies on the registry are indexed under Lupus Erythematosus, Discoid; 6 are open to participants now.
This study's enrollment of 8 is below the median of 45 across 31 interventional studies indexed under Lupus Erythematosus, Discoid.
Browse Lupus Erythematosus, Discoid studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
Drug: CC-10004
20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
Also known as: Apremilast
Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms
To evaluate the clinical response of cutaneous lupus patients to CC-10004. From J Invest Dermatol. 2005 Nov; 125(5): 889-894.doi: 10.1111/j.0022-202X.2005.23889.x: The CLASI consists of two scores. One summarizes the activity of the disease on a scale from 0 to 30, higher score translates to more severe disease. The second is a measure of the damage done by the disease on a scale form 0 to 30, higher score translates to more severe disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. Each score is reported separately. Outcome measures are reported for each time point for each subject due to the low numbers of enrollment.
Time frame: 16 Weeks
Dermatology Quality of Life Index (DQLI)
1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures
Time frame: 16 Weeks
Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 16
Dermal and Circulating Blood Plasmacytoid Dendritic Cell Levels
Time frame: Weeks 0, 4 (dermal and circulating); week 12 (circulating only)
Dermal and Circulating Blood T Regulatory Cell Levels
1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures
Time frame: Weeks 0, 4 (dermal and blood); Week 12 (blood only)
Plasma Cytokine Levels
1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures
Time frame: Weeks 0, 4, 12
Drs. Franks/Oliver and other physician (attendings) would refer subjects to the unit if they were interested.
| Milestone | Apremilast |
|---|---|
| Started | 12 |
| Completed | 8 |
| Not completed | 4 |
| Withdrew: Subject noncompliance | 2 |
| Withdrew: Adverse event | 2 |
To evaluate the clinical response of cutaneous lupus patients to CC-10004. From J Invest Dermatol. 2005 Nov; 125(5): 889-894.doi: 10.1111/j.0022-202X.2005.23889.x: The CLASI consists of two scores. One summarizes the activity of the disease on a scale from 0 to 30, higher score translates to more severe disease. The second is a measure of the damage done by the disease on a scale form 0 to 30, higher score translates to more severe disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. Each score is reported separately. Outcome measures are reported for each time point for each subject due to the low numbers of enrollment.
No measurements were reported for this outcome.
1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures
No measurements were reported for this outcome.
1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures
No measurements were reported for this outcome.
No measurements were reported for this outcome.
1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures
No measurements were reported for this outcome.
1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures
No measurements were reported for this outcome.
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Apremilast | — | 2/8 (25%) | 4/8 (50%) |
| Event | Apremilast |
|---|---|
| Lichenoid DermatitisSkin and subcutaneous tissue disorders | 1/8 |
| Neuraopathy SensoryNervous system disorders | 1/8 |
| Event | Apremilast |
|---|---|
| NauseaGastrointestinal disorders | 4/8 |
| HeadacheNervous system disorders | 2/8 |
| DiarrheaGastrointestinal disorders | 1/8 |
Must be male or female and aged ≥ 18 years at time of consent Must have a clinical exam consistent with discoid lupus erythematosus as follows: the presence of chronic cutaneous lesions without evidence of systemic disease of lupus
| Age, Categorical(Participants) | Apremilast |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Apremilast |
|---|---|
| Female | 7 |
| Male | 1 |
| Region of Enrollment(participants) | Apremilast |
|---|---|
| United States | 8 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health