NCT01946880 (ALE06) is a Phase 2 clinical trial of Mycophenolate Mofetil in Systemic Lupus Erythematosus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT01946880?

NCT01946880 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT01946880?

Interventions in NCT01946880: Mycophenolate Mofetil, Hydroxychloroquine or Chloroquine, Prednisone.

What condition does NCT01946880 study?

NCT01946880 studies Systemic Lupus Erythematosus, SLE.

Is NCT01946880 still recruiting?

NCT01946880 is currently terminated. Last updated 17 August 2020.

Are results published for NCT01946880?

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

Last reviewed 2020-08-17 · How we verify

NCT01946880: ALE06

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

Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)

Terminated Phase 2 Results posted Last updated 17 August 2020

What this trial tests

Phase 2 trial testing Mycophenolate Mofetil in Systemic Lupus Erythematosus in 102 participants. Terminated before completion.

Timeline

20 November 2013

Primary endpoint
3 July 2019

3 July 2019

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	20 November 2013
Primary completion	3 July 2019
Estimated completion	3 July 2019
Sites	19 locations across United States

Drugs / interventions tested

Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
Hydroxychloroquine or Chloroquine — full drug profile →
Prednisone (prednisone) — full drug profile →

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
SLE — all drugs for SLE →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 70, any sex, with Systemic Lupus Erythematosus or SLE. 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.

Number of Participants Experiencing Clinically Significant Disease Reactivation by Week 60 Primary · Baseline (Treatment Randomization) to Week 60

Disease reactivation requires:1) SELENA-SLEDAI mild/moderate or severe flare,and 2) Increased immunosuppressive therapy on a sustained basis,defined by one of the following criteria:a) Sustained activity:Significant prolonged SLE flare requiring steroid increase/burst to ≥15 mg/day prednisone (or equivalent) for \>4 weeks.b) Frequent relapsing/remitting:Participant flares requiring an increase/burst of steroids and is successfully tapered to \<15 mg/day within 4 weeks, but this occurs on \>2 occasions, or IA, IM or IV steroids on more than1 occasion.c)Clinical activity of sufficient severity t

Group	Value	95% CI
MMF Maintenance	5
MMF Withdrawal	9

Time to Clinically Significant Disease Reactivation Secondary · Baseline (Treatment Randomization) to Week 60

The time to clinically significant disease reactivation was defined as the time from Baseline/Day 0 to the date of the first Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) assessment that met (or went on to meet) the criteria for clinically significant disease reactivation. Time to clinically significant disease reactivation was defined in study weeks as: date of SELENA-SLEDAI assessment that met reactivation criteria minus (-) baseline date.

Group	Value	95% CI
MMF Maintenance	38.0	± 18.7
MMF Withdrawal	38.5	± 19.6

Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Secondary · Baseline (Treatment Randomization) to Week 60

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

Group	Value	95% CI
MMF Maintenance	20
MMF Withdrawal	25

Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup Secondary · Baseline (Treatment Randomization) to Week 60

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

Group	Value	95% CI
MMF Maintenance	15
MMF Withdrawal	19

Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup Secondary · Baseline (Treatment Randomization) to Week 60

Group	Value	95% CI
MMF Maintenance	5
MMF Withdrawal	6

Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF<2000 mg/Day Subgroup Secondary · Baseline (Treatment Randomization) to Week 60

Group	Value	95% CI
MMF Maintenance	11
MMF Withdrawal	13

Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup Secondary · Baseline (Treatment Randomization) to Week 60

Group	Value	95% CI
MMF Maintenance	9
MMF Withdrawal	12

Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Secondary · Baseline (Treatment Randomization) to Week 60

Group	Value	95% CI
MMF Maintenance	4
MMF Withdrawal	8

Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup Secondary · Baseline (Treatment Randomization) to Week 60

Group	Value	95% CI
MMF Maintenance	3
MMF Withdrawal	7

Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup Secondary · Baseline (Treatment Randomization) to Week 60

Group	Value	95% CI
MMF Maintenance	1
MMF Withdrawal	1

Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF <2000 mg/Day Subgroup Secondary · Baseline (Treatment Randomization) to Week 60

Group	Value	95% CI
MMF Maintenance	3
MMF Withdrawal	6

Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup Secondary · Baseline (Treatment Randomization) to Week 60

Group	Value	95% CI
MMF Maintenance	1
MMF Withdrawal	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 60 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Maintenance

Serious: 7/50 (14%)

Deaths: 0/50

Withdrawal

Serious: 5/52 (10%)

Deaths: 0/52

Serious adverse events (15 terms)

Reaction	System	Maintenance	Withdrawal
Lupus nephritis	Renal and urinary disorders	—	—
Myocardial ischaemia	Cardiac disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Acute coronary syndrome	Cardiac disorders	—	—
Pericarditis	Cardiac disorders	—	—
Haematemesis	Gastrointestinal disorders	—	—
Pancreatitis	Gastrointestinal disorders	—	—
Bronchitis	Infections and infestations	—	—
Mastoiditis	Infections and infestations	—	—
Pyelonephritis	Infections and infestations	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Psychotic disorder	Psychiatric disorders	—	—
Hidradenitis	Skin and subcutaneous tissue disorders	—	—

Other adverse events (17 terms — click to expand)

Reaction	System	Maintenance	Withdrawal
Upper respiratory tract infection	Infections and infestations	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Glomerular filtration rate decreased	Investigations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—
Headache	Nervous system disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	—	—
Bronchitis	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—
Tooth infection	Infections and infestations	—	—
Blood creatinine increased	Investigations	—	—
Acute prerenal failure	Renal and urinary disorders	—	—

Most-reported serious reactions: Lupus nephritis, Myocardial ischaemia, Febrile neutropenia, Acute coronary syndrome, Pericarditis, Haematemesis, Pancreatitis, Bronchitis.

Data from ClinicalTrials.gov NCT01946880 adverse events section.

Sponsor's own description

This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.

Publications & conference data

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

Update on Lupus Nephritis.
Almaani S, Meara A, Rovin BH. · · 2017 · cited 605× · PMID 27821390 · DOI 10.2215/cjn.05780616
Chloroquine analogues in drug discovery: new directions of uses, mechanisms of actions and toxic manifestations from malaria to multifarious diseases.
Al-Bari MA. · · 2015 · cited 293× · PMID 25693996 · DOI 10.1093/jac/dkv018
Role of lysosomes in physiological activities, diseases, and therapy.
Zhang Z, Yue P, Lu T, Wang Y, et al · · 2021 · cited 238× · PMID 33990205 · DOI 10.1186/s13045-021-01087-1
Current and Emerging Therapies for Lupus Nephritis.
Parikh SV, Rovin BH. · · 2016 · cited 68× · PMID 27283496 · DOI 10.1681/asn.2016040415
Modulation of the immunity and inflammation by autophagy.
Gan T, Qu S, Zhang H, Zhou XJ. · · 2023 · cited 27× · PMID 37405276 · DOI 10.1002/mco2.311
Mycophenolate mofetil withdrawal in patients with systemic lupus erythematosus: a multicentre, open-label, randomised controlled trial.
Chakravarty EF, Utset T, Kamen DL, Contreras G, et al · · 2024 · cited 24× · PMID 38301682 · DOI 10.1016/s2665-9913(23)00320-x
Overview of pathophysiology and treatment of human lupus nephritis.
Trotter K, Clark MR, Liarski VM. · · 2016 · cited 12× · PMID 27341623 · DOI 10.1097/bor.0000000000000319

Verify or expand the search:

Other trials of Mycophenolate Mofetil

Trials testing the same drug.

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Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

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NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

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NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet 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 NCT01946880 (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 National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 17 August 2020

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/NCT01946880.

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